Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports

Am J Psychiatry. 2003 Apr;160(4):790-2. doi: 10.1176/appi.ajp.160.4.790.


Objective: Previous reports suggesting that selective serotonin reuptake inhibitor (SSRI) use is associated with increased suicidal risk have not assessed completed suicides. The authors analyzed reports from randomized controlled trials to compare suicide rates among depressed patients assigned to an SSRI, other antidepressants, or placebo.

Method: Food and Drug Administration (FDA) summary reports of the controlled clinical trials for nine modern FDA-approved antidepressants provided data for comparing rates of suicide.

Results: Of 48,277 depressed patients participating in the trials, 77 committed suicide. Based on patient exposure years, similar suicide rates were seen among those randomly assigned to an SSRI (0.59%, 95% confidence interval [CI]=0.31%-0.87%), a standard comparison antidepressant (0.76%, 95% CI=0.49%-1.03%), or placebo (0.45%, 95% CI=0.01%-0.89%).

Conclusions: These findings fail to support either an overall difference in suicide risk between antidepressant- and placebo-treated depressed subjects in controlled trials or a difference between SSRIs and either other types of antidepressants or placebo.

Publication types

  • Comparative Study

MeSH terms

  • Access to Information
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Antidepressive Agents / adverse effects*
  • Antidepressive Agents / therapeutic use
  • Chi-Square Distribution
  • Depressive Disorder / drug therapy*
  • Humans
  • Placebos
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Selective Serotonin Reuptake Inhibitors / adverse effects*
  • Selective Serotonin Reuptake Inhibitors / therapeutic use
  • Suicide / statistics & numerical data*
  • Suicide, Attempted / statistics & numerical data
  • United States
  • United States Food and Drug Administration / statistics & numerical data


  • Antidepressive Agents
  • Placebos
  • Serotonin Uptake Inhibitors