A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in Patients with Bipolar Disorder, Mixed or Depressed Phase, and Alcohol Dependence

Brown, E. Sherwood; Davila, Domingo; Nakamura, Alyson; Carmody, Thomas J.; Rush, A. John; Lo, Alexander; Holmes, Traci; Adinoff, Bryon; Caetano, Raul; Swann, Alan C.; Sunderajan, Prabha; Bret, Mary E.

doi:10.1111/acer.12445

Cited by 50Bipolar Disorder and TreatmentSubstance Abuse Treatment and OutcomesSchizophrenia research and treatment

A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in Patients with Bipolar Disorder, Mixed or Depressed Phase, and Alcohol Dependence

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Brown, E. Sherwood, Davila, Domingo, Nakamura, Alyson, Carmody, Thomas J., Rush, A. John, Lo, Alexander, Holmes, Traci, Adinoff, Bryon +4 more·2014·Alcoholism: Clinical and Experimental Research

DOI 10.1111/acer.12445PMC PMC4107121

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Abstract

BACKGROUND: Alcohol dependence is common in bipolar disorder (BPD) and associated with treatment nonadherence, violence, and hospitalization. Quetiapine is a standard treatment for BPD. We previously reported improvement in depressive symptoms, but not alcohol use, with quetiapine in BPD and alcohol dependence. However, mean alcohol use was low and a larger effect size on alcohol-related measures was observed in those with higher levels of alcohol consumption. In this study, efficacy of quetiapine in patients with BPD and alcohol dependence was examined in patients with higher mean baseline alcohol use than in the prior study. METHODS: Ninety outpatients with bipolar I or II disorders, depressed or mixed mood state, and current alcohol dependence were randomized to 12 weeks of sustained release quetiapine (to 600 mg/d) add-on therapy or placebo. Drinking was quantified using the Timeline Follow Back method. Additional assessment tools included the Hamilton Rating Scale for Depression, Inventory of Depressive Symptomatology-Self-Report, Young Mania Rating Scale, Penn Alcohol Craving Scale, liver enzymes, and side effects. Alcohol use and mood were analyzed using a declining-effects random-regression model. RESULTS: Baseline and demographic characteristics in the 2 groups were similar. No significant between-group differences were observed on the primary outcome measure of drinks per day or other alcohol-related or mood measures (p > 0.05). Overall side effect burden, glucose, and cholesterol were similar in the 2 groups. However, a significant weight increase was observed with quetiapine at week 6 (+2.9 lbs [SE 1.4] quetiapine vs. -2.0 lbs [SE 1.4], p = 0.03), but not at week 12. Scores on the Barnes Akathisia Scale increased significantly more (p = 0.04) with quetiapine (+0.40 [SE 0.3]) than placebo (-0.52 [SE 0.3]) at week 6 but not week 12. Retention (survival) in the study was similar in the groups. CONCLUSIONS: Findings suggest that quetiapine does not reduce alcohol consumption in patients with BPD and alcohol dependence.

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Quetiapine add-on therapy was not more effective than placebo add-on in reducing the number of drinks per day or other alcohol-related measures in patients with bipolar I and bipolar II disorder with alcohol dependence (level 1 negative).
“Quetiapine add‐on therapy was not more effective than placebo add‐on in reducing the number of drinks per day or other alcohol‐related measures in patients with BDI699 or BDI and BDII with alcohol dependence (level 1 negative).700”
From Canadian Network for Mood and Anxiety Treatments ( <scp>CANMAT</scp> ) and International Society for Bipolar Disorders ( <scp>ISBD</scp> ) 2018 guidelines for the management of patients with bipolar disorder (2018) · cites this paper as [700]

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A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Outpatients With Bipolar Disorder and Alcohol Use Disorders
Brown, E. S., Garza, M. J., & Carmody, T. J. (2008) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v69n0502 · Cited by 101 · see citing works
Self-citation
A Double‐Blind, Placebo‐Controlled Study With Quetiapine as Adjunct Therapy With Lithium or Divalproex in Bipolar I Patients With Coexisting Alcohol Dependence
Stedman, M., Pettinati, H. M., Brown, E. S., Kotz, M., Calabrese, J. R., & Raines, S. (2010) · Alcoholism: Clinical and Experimental Research · doi:10.1111/j.1530-0277.2010.01270.x · Cited by 70 · see citing works
Self-citation
A Pilot Study of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence
Brown, E. S., Gabrielson, B., & Gu, P. (2010) · Journal of Dual Diagnosis · doi:10.1080/15504260903405347 · Cited by 8 · see citing works
Self-citation
Quetiapine decreases alcohol consumption, craving, and psychiatric symptoms in dually diagnosed alcoholics
Martinotti, G., Andreoli, S., Nicola, M. D., Giannantonio, M. D., Sarchiapone, M., & Janiri, L. (2008) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.944 · Cited by 89 · see citing works
A Double‐Blind, Placebo‐Controlled Trial to Assess the Efficacy of Quetiapine Fumarate XR in Very Heavy‐Drinking Alcohol‐Dependent Patients
Litten, R. Z., Fertig, J. B., Falk, D. E., Ryan, M. L., Mattson, M. E., Collins, J. F., Murtaugh, C., Ciraulo, D. A., Green, A. I., Johnson, B. A., et al. (2011) · Alcoholism Clinical and Experimental Research · doi:10.1111/j.1530-0277.2011.01649.x · Cited by 94 · see citing works

Authors: Brown, E. S., Davila, D., Nakamura, A., Carmody, T. J., Rush, A. J., Lo, A., Holmes, T., Adinoff, B., Caetano, R., Swann, A. C., Sunderajan, P., & Bret, M. E.
Affiliations: The University of Texas Southwestern Medical Center (US)
National University of Singapore (SG)
Department of Psychiatry; The University of Texas Southwestern Medical Center; Dallas Texas
Baylor College of Medicine (US)
Corresponding author: Brown, E. Sherwood
ORCID: Brown, E. Sherwood
Nakamura, Alyson
Carmody, Thomas J.
Rush, A. John
Adinoff, Bryon
Swann, Alan C.
Venue: Alcoholism: Clinical and Experimental Research
Publisher: Wiley
Published: 2014-06-27
Volume: 38
Issue: 7
Pages: 2113-2118
ISSN: 0145-6008 (ISSN-L)
DOI: 10.1111/acer.12445
PMC: PMC4107121
OpenAlex: W2042340338
Cited by: 50
References: 34
Citations by year: 2026: 2 · 2025: 1 · 2024: 4 · 2023: 4 · 2022: 4 · 2021: 5 · 2020: 2 · 2019: 2 · 2018: 4 · 2017: 9 · 2016: 9 · 2015: 3 · 2014: 1
FWCI: 5.59
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 431 d)
Locations: Alcoholism Clinical and Experimental Research (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: NIH (AA016379)
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 disorder, alcoholism, alcohol consumption, adjunctive therapy, mixed states, depressive phase, weight gain, akathisia, alcohol craving, medication adherence
MeSH terms: Quetiapine Fumarate, Adult, Alcohol Drinking, Alcoholism, Bipolar Disorder, Delayed-Action Preparations, Dibenzothiazepines, Double-Blind Method, Female, Humans, Male, Psychiatric Status Rating Scales, Antipsychotic Agents, Treatment Outcome, Diagnosis, Dual (Psychiatry), Young Adult, Craving

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A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in Patients with Bipolar Disorder, Mixed or Depressed Phase, and Alcohol Dependence

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