Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.
1 other identifier
interventional
115
1 country
1
Brief Summary
The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedApril 4, 2016
April 1, 2016
1.8 years
September 15, 2005
April 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Standard Drinks
Weekly
Study Arms (2)
Quetiapine
ACTIVE COMPARATORQuetiapine
Placebo
PLACEBO COMPARATORInactive ingredient matching the active medication in appearance
Interventions
Eligibility Criteria
You may qualify if:
- Bipolar I or II
- Ages 18-70
You may not qualify if:
- Life threatening medical condition causing participation in the study hazardous
- Alcohol abuse within the past 2 weeks
- History of cataracts or likely cataracts on baseline eye exam
- History of hepatic cirrhosis or AST or ALT more than three times normal limit
- Current active suicidal or homicidal ideation
- History of allergic reaction, poor response or intolerable side effects to quetiapine
- Antipsychotic use within 7 days of beginning quetiapine therapy
- Mental retardation, dementia or other severe cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8843, United States
Related Publications (1)
Brown ES, Garza M, Carmody TJ. A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry. 2008 May;69(5):701-5. doi: 10.4088/jcp.v69n0502.
PMID: 18312058DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E. Sherwood Brown, Ph.D., M.D.
The UT Southwestern Medical Center at Dallas
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
November 1, 2002
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
April 4, 2016
Record last verified: 2016-04