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Meeting Summary

Exploring Options to Assess Treatment Safety: Community Assessment of the Safety of Psychotropic Medications in Children and Adolescents

November 3, 2004
Washington, DC

Naitonal Institute of Mental Health


The use of psychotropic medications in children has increased dramatically in recent years. There is much concern in the community about possible effects of these drugs when given during development and potential long-term negative impacts. Standard clinical trials have an important but limited role in the assessment of drug safety because the duration of clinical trials is typically short and the sample size allows the detection of only frequently occurring adverse events. There is a need for information about long-term effects of treatments and on the possible association between treatment and infrequent but serious adverse events, such as suicidal behavior. For this reason, novel approaches to studying the safety of psychotropic medications in children are warranted.

Aims of the Meeting:

Main Conclusions