Citation

Wightman DS, Foster VJ, Krishen A, Richard NE, Modell JG. Prim. Care Companion J. Clin. Psychiatry 2010; 12(5): e1-e8.

Copyright

(Copyright © 2010, Physicians Postgraduate Press)

DOI

10.4088/PCC.09m00894blu

PMID

unavailable

Abstract

Data Sources: This analysis, based on the US Food and Drug Administration's (FDA's) analysis of antidepressant suicidality data, included 8,953 adult subjects receiving bupropion and 6,520 adult subjects receiving placebo from randomized, placebo-controlled trials with bupropion conducted between 1976 and 2006 across multiple indications, including major depressive disorder (MDD). A text string search of the adverse event database and case report form comments was performed to identify potential suicidal events. FDA search criteria included the following text strings: accident-, injur-, suic-, or overdos-, including all events coded as accidental overdose, attempt, cut, gas, hang, hung, jump, mutilat-, self damag-, self harm, self inflict-, shoot, slash, poison, asphyxiation, suffocation, firearm, burn, drown, gun, immolat-, and monoxide, and the following terms were added by GlaxoSmithKline to the search criteria: accident, lacerat-, MVA, and hospital. The database search included data beginning from the first dose of study medication through 1 day following the last dose. Data Extraction: Suicidal event narratives were classified using the Columbia Classification Algorithm for Suicide Assessment. Additionally, changes on rating scale items for depressed mood and suicidality were analyzed. Data Synthesis: In the MDD population, the incidence of suicidal behavior or ideation was 17/3,179 (0.53%) versus 11/2,310 (0.48%) for the bupropion and placebo groups, respectively (OR = 1.28; 95% CI, 0.59-2.86). For suicidal behavior, the incidence was 8/3,179 (0.25%) versus 2/2,310 (0.09%), respectively (OR = 3.52; 95% CI, 0.81-24.48). No suicidal behavior event was noted in the other indications, and no completed suicides were reported during treatment. No significant worsening was observed for bupropion relative to placebo on the rating scale items. No differential treatment effects were observed by gender or age; regardless of treatment, however, the 18- to 24-year-old group had the greatest odds of having a suicide event.

CONCLUSIONS: Although no statistically significant differences were observed between bupropion and placebo in expressed suicidal ideation or behavior, we believe that all patients treated with antidepressants should receive careful monitoring for clinical worsening, suicidality, or unusual changes in behavior. © 2010 Physicians Postgraduate Press, Inc.

Language: en

Keywords

human; age; systematic review; suicidal ideation; sex difference; randomized controlled trial; drug use; major depression; suicidal behavior; clinical trial; article; rating scale; amfebutamone; patient monitoring; controlled clinical trial; placebo; meta analysis; drug indication; smoking cessation; outcome assessment; seasonal affective disorder