Report

CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary

Released:: May 4, 2010
Type:: Workshop Summary
Topics:: Biomedical and Health Research, Substance Abuse and Mental Health, Quality and Patient Safety
Activity:: Forum on Neuroscience and Nervous System Disorders
Board:: Board on Health Sciences Policy

Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM. Learn more about the differences between Workshop Summaries and Consensus Reports.

Since 1991, professionals have wrestled with the possibility that the very medications given to combat depression also may contribute, in a minority of cases, to suicidal ideation, suicidal behavior—such as preparing for or attempting suicide—and completed suicides. Recently, the Food and Drug Administration (FDA) began requiring that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. Because suicide, despite its seriousness, is relatively rare in the population as a whole, it is difficult to detect whether or not a medication will cause any suicide-related behavior. Even if researchers could better detect the risk for suicide, it is difficult to separate the variables and determine whether depression, or the medication to treat depression, is responsible.

The IOM’s Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA’s new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future.

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