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Cited by 70Bipolar Disorder and TreatmentSubstance Abuse Treatment and OutcomesSchizophrenia research and treatment

A Double‐Blind, Placebo‐Controlled Study With Quetiapine as Adjunct Therapy With Lithium or Divalproex in Bipolar I Patients With Coexisting Alcohol Dependence

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Stedman, Mary, Pettinati, Helen M., Brown, E. Sherwood, Kotz, Margaret, Calabrese, Joseph R., Raines, Shane·2010·Alcoholism: Clinical and Experimental Research
DOI 10.1111/j.1530-0277.2010.01270.x
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Abstract

Background: This study evaluated the efficacy of quetiapine versus placebo as an adjunct to lithium or divalproex in reducing alcohol consumption in patients with bipolar I disorder and coexisting alcohol dependence. Methods: Male and female outpatients (21 to 60 years) with a history of bipolar I disorder and alcohol dependence were included in this 12‐week, placebo‐controlled study. Patients treated with lithium or divalproex (ongoing or assigned at screening) were randomized to receive quetiapine (dosed up to 400 mg/d over 7 days, followed by 300 to 800 mg/d flexible dosing until study end) or placebo. The primary outcome measure was the change in the proportion of heavy drinking days from baseline to Week 12 (as derived from the Timeline Followback method). Secondary outcome measures included time to the first consecutive 2 weeks of abstinence, changes from baseline to Week 12 in the proportion of nondrinking days, mean number of standardized drinks per day, and Clinical Global Impressions‐Severity of Illness score. Results: Of 362 enrolled patients (mean 38.6 years), 176 were randomized to receive quetiapine and 186 to placebo. The mean proportion of heavy drinking days at baseline was 0.66 in the quetiapine group and 0.67 in the placebo group. At Week 12, the mean change in the proportion of heavy drinking days was −0.36 with quetiapine and −0.36 with placebo (p = 0.93). No statistically significant differences in any of the secondary outcome measures were noted between the quetiapine and placebo groups. The incidence of adverse events was consistent with the previously known tolerability profile of quetiapine. Conclusions: The efficacy of quetiapine in the treatment of bipolar disorder is already well established. In this study, however, quetiapine added to lithium or divalproex did not result in significantly greater improvement compared with placebo in measures of alcohol use and dependence in patients with bipolar I disorder and alcohol dependence.

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  1. [12]12. Guy W (ed). (1976) ECDEU assessment manual for psychopharmacology: publication ADM 76-338. pp. 218-222. US Department of Health, Educa- tion and Welfare, Washington, DC.

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Authors
Stedman, M., Pettinati, H. M., Brown, E. S., Kotz, M., Calabrese, J. R., & Raines, S.
Affiliations
University Hospitals of Cleveland (US)
Corresponding author
Stedman, Mary
ORCID
Venue
Alcoholism: Clinical and Experimental Research
Publisher
Wiley
Published
2010-07-09
Volume
34
Issue
10
Pages
1822-1831
ISSN
  • 0145-6008 (ISSN-L)
  • 1530-0277
DOI
10.1111/j.1530-0277.2010.01270.x
OpenAlex
W1894074161
Cited by
70
References
25
Citations by year
2026: 1 · 2025: 3 · 2024: 2 · 2023: 4 · 2022: 3 · 2021: 4 · 2020: 1 · 2019: 3 · 2018: 4 · 2017: 11 · 2016: 2 · 2015: 8 · 2014: 7 · 2013: 2 · 2012: 9
FWCI
3.72
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Alcoholism Clinical and Experimental Research (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • U.S. Department of Veterans Affairs
  • Eli Lilly and Company
  • AstraZeneca
  • GlaxoSmithKline
  • Yale University
  • University of Pennsylvania
  • University of Texas Southwestern Medical Center
  • National Alliance for Research on Schizophrenia and Depression
  • Dainippon Sumitomo Pharma
  • Servier
  • H. Lundbeck A/S
  • National Institute on Alcohol Abuse and Alcoholism
  • National Institute of Mental Health
  • National Institute on Drug Abuse
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
quetiapine, bipolar I disorder, alcoholism, adjunctive pharmacotherapy, lithium, divalproex, alcohol consumption, heavy drinking days, alcohol abstinence, atypical antipsychotics
MeSH terms
Quetiapine Fumarate, Adult, Alcohol Drinking, Alcoholism, Bipolar Disorder, Dibenzothiazepines, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Antipsychotic Agents, Valproic Acid, Diagnosis, Dual (Psychiatry), Lithium Compounds, Antimanic Agents

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