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Meeting Summary

Assessing Suicidality During Antidepressant Treatment

November 9, 2005 – November 10, 2005
Bethesda, Maryland

Sponsored by:
Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH) and NIH Office of Rare Diseases (ORD)

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The purpose of this 1 1/2-day workshop was to consider systematic approaches to assessing and studying suicidality and other related adverse events potentially occurring during treatment with antidepressant medications, in order to enhance both basic research on understanding the pharmacologic mechanisms of these agents, as well as research that addresses practical questions of relevance to practitioners, patients, and families (see agenda). The meeting was sponsored by the National Institutes of Health (NIH) Office of Rare Diseases and the National Institute of Mental Health. Participants included suicidologists, other researchers with expertise in a broad array of disciplines, Food and Drug Administration (FDA) participants, and other stakeholders (see participant list). The following is a summary of the discussion and recommended points for consideration.

Issues in the Assessment/Measurement of SSRI Side Effects in Trials

To set the context for the meeting, the workshop began with a set of presentations that summarized the series of events that led to the FDA’s review of antidepressant medications and subsequent warnings. Based on variability in classification of spontaneously-reported adverse events (AEs) across industry-sponsored trials, the FDA consulted outside experts to develop and apply guidelines for operationalizing potential suicide-related AEs. Results based on re-coded data from 24 pediatric trials in 9 drug development programs (5 SSRIs, 4 atypicals) including the NIMH-sponsored Treatment for Adolescents with Depression Study, indicated that antidepressant treatment was associated with an increased risk for suicide-related AEs but not suicide deaths compared with placebo; there was variability in risk across trials and across agents

Federally sponsored clinical trials typically include systematically collected AE data. The ongoing Treatment of Adolescent Suicide Attempters study employs the Safety Monitoring Uniform Report Form (general inquiry, body systems review, drug-specific inquiries) plus a review of 13 drug-specific putative triggers for suicidality (e.g., irritability, emotional lability). Similarly, typical adult trials include the use of scales that include systems review and specific inquiries.

Discussion highlighted the following points for consideration when interpreting data from extant trials and designing future research:

Strategies and Methods that Might Illuminate the Putative Relationship between SSRIs and Suicidality

Additional presentations illustrated a broad array of research approaches and methods that either have been applied or could potentially be applied to improve our understanding of pressing questions.

Additional Points for Consideration and Summary

The presentations and discussion illustrated how limitations in current assessment methods, including definitional problems (e.g., differentiating suicidal vs. self-harm behavior, operationalizing “intent”) and lack of reliable methods, and the transitory, private nature of the phenomenon itself, complicate assessment of suicidality. Discussion also highlighted points for consideration when developing, selecting, or administering instruments to assess suicidality, including:

A number of relevant, pressing, potentially researchable questions were noted, including:


The workshop presentations and discussion suggest that there might be important qualitative differences in the type of information obtained from different sources (e.g., self-report/subjective vs. clinician-rated/more objective), thus, highlighting the need for broad assessment and data integration. The presentations also demonstrated the potential relevance of various research platforms (e.g., RCTs, large public/private databases) and approaches (applications of basic behavioral/cognitive research methods, pharmacogentic/pharmacokinetic approaches). Given the low base rate of suicidality during antidepressant treatment, and given the challenges inherent in studying it, innovative methods and study designs need to be considered to address if, when, and how antidepressant treatment might be associated with suicidality.