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ACG/ASGE Task Force Identifies 19 Indicators for Achieving Quality GI Endoscopy
— most of which have a performance target > 98%, implying they should be achieved in nearly every case.
The task force’s work was published online in The American Journal of Gastroenterology.
“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview.
“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?
“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
Four Priority Indicators
The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.
As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).
While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:
- Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%)
- Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%)
- Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%)
- Frequency with which adverse events are documented (performance target > 98%)
Room for Improvement
There remains a lack of compliance with some of these indicators, the task force said.
“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.
“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote.
The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.
Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”
“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.
In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.
This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.
A version of this article first appeared on Medscape.com.
— most of which have a performance target > 98%, implying they should be achieved in nearly every case.
The task force’s work was published online in The American Journal of Gastroenterology.
“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview.
“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?
“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
Four Priority Indicators
The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.
As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).
While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:
- Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%)
- Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%)
- Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%)
- Frequency with which adverse events are documented (performance target > 98%)
Room for Improvement
There remains a lack of compliance with some of these indicators, the task force said.
“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.
“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote.
The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.
Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”
“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.
In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.
This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.
A version of this article first appeared on Medscape.com.
— most of which have a performance target > 98%, implying they should be achieved in nearly every case.
The task force’s work was published online in The American Journal of Gastroenterology.
“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview.
“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?
“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
Four Priority Indicators
The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.
As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).
While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:
- Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%)
- Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%)
- Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%)
- Frequency with which adverse events are documented (performance target > 98%)
Room for Improvement
There remains a lack of compliance with some of these indicators, the task force said.
“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.
“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote.
The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.
Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”
“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.
In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.
This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Five Key Measures to Ensure a Quality Colonoscopy
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
Ivonescimab: Possible New First-Line Standard in PD-L1–Positive Advanced NSCLC?
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
FROM WCLC 2024
Brain Network Significantly Larger in People With Depression, Even in Childhood
Researchers have discovered that
Using a novel brain-mapping technique, researchers found that the frontostriatal salience network was expanded nearly twofold in the brains of most individuals studied with depression compared with controls.
“This expansion in cortex was trait-like, meaning it was stable over time and did not change as symptoms changed over time,” said lead author Charles Lynch, PhD, assistant professor of neuroscience, Department of Psychiatry, Weill Cornell Medicine in New York.
It could also be detected in children who later developed depression, suggesting it may serve as a biomarker of depression risk. Investigators said the findings could aid in prevention and early detection of depression, as well as the development of more personalized treatment.
The study was published online in Nature.
Prewired for Depression?
Precision functional mapping is a relatively new approach to brain mapping in individuals that uses large amounts of fMRI data from hours of scans per person. The technique has been used to show differences in brain networks between and in healthy individuals but had not been used to study brain networks in people with depression.
“We leveraged our large longitudinal datasets — with many hours of functional MRI scanning per subject — to construct individual-specific maps of functional brain networks in each patient using precision functional mapping, instead of relying on group average,” Dr. Lynch said.
In the primary analysis of 141 adults with major depression and 37 healthy controls, the frontostriatal salience network — which is involved in reward processing and attention to internal and external stimuli — was markedly larger in these individuals with depression.
“This is one of the first times these kinds of personalized maps have been created in individuals with depression, and this is how we first observed of the salience network being larger in individuals with depression,” Dr. Lynch said.
In four of the six individuals, the salience network was expanded more than twofold, outside the range observed in all 37 healthy controls. On average, the salience network occupied 73% more of the cortical surface relative to the average in healthy controls.
The findings were replicated using independent samples of repeatedly sampled individuals with depression and in large-scale group average data.
The expansion of the salience network did not change over time and was unaffected by changes in mood state.
“These observations led us to propose that instead of driving changes in depressive symptoms over time, salience network expansion may be a stable marker of risk for developing depression,” the study team wrote.
An analysis of brain scans from 57 children who went on to develop depressive symptoms during adolescence and an equal number of children who did not develop depressive symptoms supports this theory.
On average, the salience network occupied roughly 36% more of cortex in the children with no current or previous symptoms of depression at the time of their fMRI scans but who subsequently developed clinically significant symptoms of depression, relative to children with no depressive symptoms at any study time point, the researchers found.
Immediate Clinical Impact?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist and researcher based in Miami, said this research “exemplifies the promising intersection of neurology and digital health, where advanced neuroimaging and data-driven approaches can transform mental health care into a more precise and individualized practice,” Dr. Lakhan said. “By identifying this brain network expansion, we’re unlocking new possibilities for precision medicine in mental health.”
Dr. Lakhan, who wasn’t involved in this research, said identifying the expansion of the frontostriatal salience network in individuals with depression opens new avenues for developing novel therapeutics.
“By targeting this network through neuromodulation techniques like deep brain stimulation, transcranial magnetic stimulation, and prescription digital therapeutics, treatments can be more precisely tailored to individual neurobiological profiles,” Dr. Lakhan said. “Additionally, this network expansion could serve as a biomarker for early detection, allowing for preventive strategies or personalized treatment plans, particularly for those at risk of developing depression.”
In addition, a greater understanding of the mechanisms driving salience network expansion offers potential for discovering new pharmacological targets, Dr. Lakhan noted.
“Drugs that modulate synaptic plasticity or network connectivity might be developed to reverse or mitigate these neural changes. The findings also support the use of longitudinal monitoring to predict and preempt symptom emergence, improving outcomes through timely intervention. This research paves the way for more personalized, precise, and proactive approaches in treating depression,” Dr. Lakhan concluded.
Also weighing in, Teddy Akiki, MD, with the Department of Psychiatry and Behavioral Sciences at Stanford Medicine in California, noted that the effect size of the frontostriatal salience network difference in depression is “remarkably larger than typically seen in neuroimaging studies of depression, which often describe subtle differences. The consistency across multiple datasets and across time at the individual level adds significant weight to these findings, suggesting that it is a trait marker rather than a state-dependent marker.”
“The observation that this expansion is present even before the onset of depressive symptoms in adolescence suggests its potential as a biomarker for depression risk,” Dr. Akiki said. “This approach could lead to earlier identification of at-risk individuals and potentially inform the development of targeted preventive interventions.”
He cautioned that it remains to be seen whether interventions targeting the salience network can effectively prevent or treat depression.
This research was supported in part by the National Institute of Mental Health, the National Institute on Drug Addiction, the Hope for Depression Research Foundation, and the Foundation for OCD Research. Dr. Lynch and a coauthor are listed as inventors for Cornell University patent applications on neuroimaging biomarkers for depression which are pending or in preparation. Dr. Liston has served as a scientific advisor or consultant to Compass Pathways PLC, Delix Therapeutics, and Brainify.AI. Dr. Lakhan and Dr. Akiki had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Researchers have discovered that
Using a novel brain-mapping technique, researchers found that the frontostriatal salience network was expanded nearly twofold in the brains of most individuals studied with depression compared with controls.
“This expansion in cortex was trait-like, meaning it was stable over time and did not change as symptoms changed over time,” said lead author Charles Lynch, PhD, assistant professor of neuroscience, Department of Psychiatry, Weill Cornell Medicine in New York.
It could also be detected in children who later developed depression, suggesting it may serve as a biomarker of depression risk. Investigators said the findings could aid in prevention and early detection of depression, as well as the development of more personalized treatment.
The study was published online in Nature.
Prewired for Depression?
Precision functional mapping is a relatively new approach to brain mapping in individuals that uses large amounts of fMRI data from hours of scans per person. The technique has been used to show differences in brain networks between and in healthy individuals but had not been used to study brain networks in people with depression.
“We leveraged our large longitudinal datasets — with many hours of functional MRI scanning per subject — to construct individual-specific maps of functional brain networks in each patient using precision functional mapping, instead of relying on group average,” Dr. Lynch said.
In the primary analysis of 141 adults with major depression and 37 healthy controls, the frontostriatal salience network — which is involved in reward processing and attention to internal and external stimuli — was markedly larger in these individuals with depression.
“This is one of the first times these kinds of personalized maps have been created in individuals with depression, and this is how we first observed of the salience network being larger in individuals with depression,” Dr. Lynch said.
In four of the six individuals, the salience network was expanded more than twofold, outside the range observed in all 37 healthy controls. On average, the salience network occupied 73% more of the cortical surface relative to the average in healthy controls.
The findings were replicated using independent samples of repeatedly sampled individuals with depression and in large-scale group average data.
The expansion of the salience network did not change over time and was unaffected by changes in mood state.
“These observations led us to propose that instead of driving changes in depressive symptoms over time, salience network expansion may be a stable marker of risk for developing depression,” the study team wrote.
An analysis of brain scans from 57 children who went on to develop depressive symptoms during adolescence and an equal number of children who did not develop depressive symptoms supports this theory.
On average, the salience network occupied roughly 36% more of cortex in the children with no current or previous symptoms of depression at the time of their fMRI scans but who subsequently developed clinically significant symptoms of depression, relative to children with no depressive symptoms at any study time point, the researchers found.
Immediate Clinical Impact?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist and researcher based in Miami, said this research “exemplifies the promising intersection of neurology and digital health, where advanced neuroimaging and data-driven approaches can transform mental health care into a more precise and individualized practice,” Dr. Lakhan said. “By identifying this brain network expansion, we’re unlocking new possibilities for precision medicine in mental health.”
Dr. Lakhan, who wasn’t involved in this research, said identifying the expansion of the frontostriatal salience network in individuals with depression opens new avenues for developing novel therapeutics.
“By targeting this network through neuromodulation techniques like deep brain stimulation, transcranial magnetic stimulation, and prescription digital therapeutics, treatments can be more precisely tailored to individual neurobiological profiles,” Dr. Lakhan said. “Additionally, this network expansion could serve as a biomarker for early detection, allowing for preventive strategies or personalized treatment plans, particularly for those at risk of developing depression.”
In addition, a greater understanding of the mechanisms driving salience network expansion offers potential for discovering new pharmacological targets, Dr. Lakhan noted.
“Drugs that modulate synaptic plasticity or network connectivity might be developed to reverse or mitigate these neural changes. The findings also support the use of longitudinal monitoring to predict and preempt symptom emergence, improving outcomes through timely intervention. This research paves the way for more personalized, precise, and proactive approaches in treating depression,” Dr. Lakhan concluded.
Also weighing in, Teddy Akiki, MD, with the Department of Psychiatry and Behavioral Sciences at Stanford Medicine in California, noted that the effect size of the frontostriatal salience network difference in depression is “remarkably larger than typically seen in neuroimaging studies of depression, which often describe subtle differences. The consistency across multiple datasets and across time at the individual level adds significant weight to these findings, suggesting that it is a trait marker rather than a state-dependent marker.”
“The observation that this expansion is present even before the onset of depressive symptoms in adolescence suggests its potential as a biomarker for depression risk,” Dr. Akiki said. “This approach could lead to earlier identification of at-risk individuals and potentially inform the development of targeted preventive interventions.”
He cautioned that it remains to be seen whether interventions targeting the salience network can effectively prevent or treat depression.
This research was supported in part by the National Institute of Mental Health, the National Institute on Drug Addiction, the Hope for Depression Research Foundation, and the Foundation for OCD Research. Dr. Lynch and a coauthor are listed as inventors for Cornell University patent applications on neuroimaging biomarkers for depression which are pending or in preparation. Dr. Liston has served as a scientific advisor or consultant to Compass Pathways PLC, Delix Therapeutics, and Brainify.AI. Dr. Lakhan and Dr. Akiki had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Researchers have discovered that
Using a novel brain-mapping technique, researchers found that the frontostriatal salience network was expanded nearly twofold in the brains of most individuals studied with depression compared with controls.
“This expansion in cortex was trait-like, meaning it was stable over time and did not change as symptoms changed over time,” said lead author Charles Lynch, PhD, assistant professor of neuroscience, Department of Psychiatry, Weill Cornell Medicine in New York.
It could also be detected in children who later developed depression, suggesting it may serve as a biomarker of depression risk. Investigators said the findings could aid in prevention and early detection of depression, as well as the development of more personalized treatment.
The study was published online in Nature.
Prewired for Depression?
Precision functional mapping is a relatively new approach to brain mapping in individuals that uses large amounts of fMRI data from hours of scans per person. The technique has been used to show differences in brain networks between and in healthy individuals but had not been used to study brain networks in people with depression.
“We leveraged our large longitudinal datasets — with many hours of functional MRI scanning per subject — to construct individual-specific maps of functional brain networks in each patient using precision functional mapping, instead of relying on group average,” Dr. Lynch said.
In the primary analysis of 141 adults with major depression and 37 healthy controls, the frontostriatal salience network — which is involved in reward processing and attention to internal and external stimuli — was markedly larger in these individuals with depression.
“This is one of the first times these kinds of personalized maps have been created in individuals with depression, and this is how we first observed of the salience network being larger in individuals with depression,” Dr. Lynch said.
In four of the six individuals, the salience network was expanded more than twofold, outside the range observed in all 37 healthy controls. On average, the salience network occupied 73% more of the cortical surface relative to the average in healthy controls.
The findings were replicated using independent samples of repeatedly sampled individuals with depression and in large-scale group average data.
The expansion of the salience network did not change over time and was unaffected by changes in mood state.
“These observations led us to propose that instead of driving changes in depressive symptoms over time, salience network expansion may be a stable marker of risk for developing depression,” the study team wrote.
An analysis of brain scans from 57 children who went on to develop depressive symptoms during adolescence and an equal number of children who did not develop depressive symptoms supports this theory.
On average, the salience network occupied roughly 36% more of cortex in the children with no current or previous symptoms of depression at the time of their fMRI scans but who subsequently developed clinically significant symptoms of depression, relative to children with no depressive symptoms at any study time point, the researchers found.
Immediate Clinical Impact?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist and researcher based in Miami, said this research “exemplifies the promising intersection of neurology and digital health, where advanced neuroimaging and data-driven approaches can transform mental health care into a more precise and individualized practice,” Dr. Lakhan said. “By identifying this brain network expansion, we’re unlocking new possibilities for precision medicine in mental health.”
Dr. Lakhan, who wasn’t involved in this research, said identifying the expansion of the frontostriatal salience network in individuals with depression opens new avenues for developing novel therapeutics.
“By targeting this network through neuromodulation techniques like deep brain stimulation, transcranial magnetic stimulation, and prescription digital therapeutics, treatments can be more precisely tailored to individual neurobiological profiles,” Dr. Lakhan said. “Additionally, this network expansion could serve as a biomarker for early detection, allowing for preventive strategies or personalized treatment plans, particularly for those at risk of developing depression.”
In addition, a greater understanding of the mechanisms driving salience network expansion offers potential for discovering new pharmacological targets, Dr. Lakhan noted.
“Drugs that modulate synaptic plasticity or network connectivity might be developed to reverse or mitigate these neural changes. The findings also support the use of longitudinal monitoring to predict and preempt symptom emergence, improving outcomes through timely intervention. This research paves the way for more personalized, precise, and proactive approaches in treating depression,” Dr. Lakhan concluded.
Also weighing in, Teddy Akiki, MD, with the Department of Psychiatry and Behavioral Sciences at Stanford Medicine in California, noted that the effect size of the frontostriatal salience network difference in depression is “remarkably larger than typically seen in neuroimaging studies of depression, which often describe subtle differences. The consistency across multiple datasets and across time at the individual level adds significant weight to these findings, suggesting that it is a trait marker rather than a state-dependent marker.”
“The observation that this expansion is present even before the onset of depressive symptoms in adolescence suggests its potential as a biomarker for depression risk,” Dr. Akiki said. “This approach could lead to earlier identification of at-risk individuals and potentially inform the development of targeted preventive interventions.”
He cautioned that it remains to be seen whether interventions targeting the salience network can effectively prevent or treat depression.
This research was supported in part by the National Institute of Mental Health, the National Institute on Drug Addiction, the Hope for Depression Research Foundation, and the Foundation for OCD Research. Dr. Lynch and a coauthor are listed as inventors for Cornell University patent applications on neuroimaging biomarkers for depression which are pending or in preparation. Dr. Liston has served as a scientific advisor or consultant to Compass Pathways PLC, Delix Therapeutics, and Brainify.AI. Dr. Lakhan and Dr. Akiki had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM NATURE
Breast Cancer Hormone Therapy May Protect Against Dementia
TOPLINE:
with the greatest benefit seen in younger Black women.
METHODOLOGY:
- Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
- To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
- The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
- Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.
TAKEAWAY:
- Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
- Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
- Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
- Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).
IN PRACTICE:
Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.
“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
SOURCE:
The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.
LIMITATIONS:
The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.
DISCLOSURES:
Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
with the greatest benefit seen in younger Black women.
METHODOLOGY:
- Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
- To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
- The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
- Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.
TAKEAWAY:
- Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
- Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
- Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
- Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).
IN PRACTICE:
Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.
“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
SOURCE:
The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.
LIMITATIONS:
The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.
DISCLOSURES:
Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
with the greatest benefit seen in younger Black women.
METHODOLOGY:
- Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
- To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
- The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
- Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.
TAKEAWAY:
- Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
- Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
- Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
- Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).
IN PRACTICE:
Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.
“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
SOURCE:
The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.
LIMITATIONS:
The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.
DISCLOSURES:
Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Aspirin for CRC Prevention May Work Best in Adults With Unhealthy Lifestyles
TOPLINE:
METHODOLOGY:
- Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
- Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
- They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
- Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.
TAKEAWAY:
- During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
- The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
- The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
- Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
- The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
- Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.
IN PRACTICE:
“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote.
SOURCE:
The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome.
DISCLOSURES:
The study had no commercial funding. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
- Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
- They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
- Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.
TAKEAWAY:
- During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
- The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
- The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
- Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
- The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
- Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.
IN PRACTICE:
“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote.
SOURCE:
The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome.
DISCLOSURES:
The study had no commercial funding. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
- Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
- They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
- Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.
TAKEAWAY:
- During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
- The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
- The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
- Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
- The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
- Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.
IN PRACTICE:
“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote.
SOURCE:
The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome.
DISCLOSURES:
The study had no commercial funding. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Beyond One-Size-Fits-All: Precision Psychiatry Is Here
The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.
But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
Beyond One-Size-Fits-All
The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.
In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.
“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.
Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.
They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.
“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.
“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.
Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
Precision Tools
A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.
MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.
“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.
Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.
“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.
Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
The Future Is Already Here
The implementation and widespread adoption of precision psychiatry have several challenges.
It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.
Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.
Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.
Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.
“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.
“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.
Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.
“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.
Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.
Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
A version of this article first appeared on Medscape.com.
The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.
But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
Beyond One-Size-Fits-All
The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.
In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.
“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.
Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.
They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.
“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.
“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.
Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
Precision Tools
A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.
MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.
“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.
Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.
“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.
Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
The Future Is Already Here
The implementation and widespread adoption of precision psychiatry have several challenges.
It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.
Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.
Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.
Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.
“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.
“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.
Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.
“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.
Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.
Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
A version of this article first appeared on Medscape.com.
The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.
But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
Beyond One-Size-Fits-All
The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.
In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.
“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.
Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.
They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.
“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.
“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.
Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
Precision Tools
A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.
MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.
“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.
Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.
“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.
Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
The Future Is Already Here
The implementation and widespread adoption of precision psychiatry have several challenges.
It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.
Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.
Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.
Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.
“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.
“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.
Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.
“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.
Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.
Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Signal of Suicide Ideation With GLP-1 RA Semaglutide, but Experts Urge Caution
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
Evidence Growing for Inflammation’s Role in Elevating Risk for Psychiatric Illness
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
Severe COVID-19 Tied to Increased Risk for Mental Illness
New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health.
, particularly in those with severe COVID who had not been vaccinated.
Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found.
“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release.
The study was published online on August 21 in JAMA Psychiatry.
Novel Data
“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast.
“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said.
The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.
The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.
Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.
For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.
This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.
For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.
The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination.
“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.
Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.
“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast.
In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added.
The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health.
, particularly in those with severe COVID who had not been vaccinated.
Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found.
“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release.
The study was published online on August 21 in JAMA Psychiatry.
Novel Data
“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast.
“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said.
The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.
The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.
Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.
For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.
This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.
For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.
The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination.
“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.
Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.
“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast.
In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added.
The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health.
, particularly in those with severe COVID who had not been vaccinated.
Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found.
“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release.
The study was published online on August 21 in JAMA Psychiatry.
Novel Data
“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast.
“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said.
The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.
The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.
Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.
For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.
This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.
For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.
The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination.
“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.
Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.
“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast.
In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added.
The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.