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


METHODS
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.
Khan
Arif
A
Northwest Clinical Research Center, Bellevue, Washington, USA. akhan@nwcrc.net
Khan
Shirin
S
Kolts
Russell
R
Brown
Walter A
WA
D022126:Access to Information; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016009:Chi-Square Distribution; D003866:Depressive Disorder / Q000188:drug therapy*; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D013405:Suicide / Q000706:statistics & numerical data*; D013406:Suicide, Attempted / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data
D000928:Antidepressive Agents; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors