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Cited by 25Suicide and Self-Harm StudiesTreatment of Major DepressionPharmacovigilance and Adverse Drug Reactions

Meta-Analysis of Suicidality in Placebo-Controlled Clinical Trials of Adults Taking Bupropion

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Wightman, Donna S., Foster, Vicki J., Krishen, Alok, Richard, Nathalie E., Modell, Jack G.·2010·The Primary Care Companion to The Journal of Clinical Psychiatry
DOI 10.4088/pcc.09m00894bluPMC PMC3025994
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Abstract

OBJECTIVE: To assess a possible relationship between treatment with bupropion (vs placebo) and expressed suicidal ideation and behavior. 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.

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  • Wightman et al. found no statistically significant differences between bupropion and placebo in expressed suicidal ideation or behavior.

    “Wightman et al.37 analyzed data on antidepressant suicidality from RCTs using bupropion for multiple indications. The studies were conducted between 1976 and 2006, and no statistically significant differences were found between bupropion and placebo in terms of expressed suicidal ideation or behavior.37”

    From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [37]

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  1. [1]Centers for Disease Control and Prevention. National Vital Statistics Report. 2006;57(14) 80 pp. (PHS) 2009-1120. http://www.cdc.gov/nchs/products/nvsr.htm. Accessibility verified July 29, 2010. [PubMed] [Google Scholar]

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Authors
Wightman, D. S., Foster, V. J., Krishen, A., Richard, N. E., & Modell, J. G.
Affiliations
GlaxoSmithKline (United States) (US)
Venue
The Primary Care Companion to The Journal of Clinical Psychiatry
Publisher
Physicians Postgraduate Press, Inc
Published
2010-09-23
Volume
12
Issue
5
ISSN
  • 1523-5998 (ISSN-L)
  • 1555-211X
DOI
10.4088/pcc.09m00894blu
PMC
PMC3025994
OpenAlex
W1987721860
Cited by
25
References
1
Citations by year
2026: 1 · 2023: 3 · 2021: 2 · 2020: 1 · 2019: 2 · 2018: 1 · 2016: 4 · 2015: 1 · 2014: 2 · 2013: 4
FWCI
0.37
Type
journal article
Language
en
Open access
Locations
  • The Primary Care Companion to The Journal of Clinical Psychiatry (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
bupropion, suicidality, suicidal ideation, suicidal behavior, major depressive disorder, antidepressant side effects, young adults, antidepressant safety, bupropion overdose, depression rating scales, gender differences in suicide risk

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