Suicide Rates in Clinical Trials of SSRIs, Other Antidepressants, and Placebo: Analysis of FDA Reports

• Published in: The American journal of psychiatry 2003-04, Vol.160 (4), p.790-792
• Main Authors: Khan, Arif, Khan, Shirin, Kolts, Russell, Brown, Walter A.
• Format: Article
• Language: English
• Subjects: Access to Information; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Antidepressants; Antidepressive Agents - adverse effects; Antidepressive Agents - therapeutic use; Biological and medical sciences; Chi-Square Distribution; Clinical trials; Depression; Depressive Disorder - drug therapy; Drug toxicity and drugs side effects treatment; Ethical aspects; Humans; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Pharmacology. Drug treatments; Placebo effect; Placebos; Randomized controlled trials; Randomized Controlled Trials as Topic - statistics & numerical data; Risk management; Serotonin reuptake inhibitors; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Suicide; Suicide - statistics & numerical data; Suicide, Attempted - statistics & numerical data; Suicides & suicide attempts; Treatment; United States; United States Food and Drug Administration - statistics & numerical data; USA
• ISSN: 0002-953X; 1535-7228
• 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.