Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder
1 other identifier
interventional
350
1 country
38
Brief Summary
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2006
Shorter than P25 for phase_3
38 active sites
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
First Submitted
Initial submission to the registry
June 16, 2005
CompletedFirst Posted
Study publicly available on registry
June 17, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 4, 2013
January 1, 2013
June 16, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Secondary Outcomes (2)
Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
Interventions
Eligibility Criteria
You may qualify if:
- Meets criteria for Bipolar I Disorder with Alcohol dependence
- Outpatient Status
- Recent history of heavy drinking
You may not qualify if:
- Unstable medical illness
- Recent antipsychotic use
- Poorly controlled Diabetes Mellitus or Diabetes related illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
Research Site
Cerritos, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Orlando, Florida, United States
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Eagle, Idaho, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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Moorestown, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Research Triangle Park, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2005
First Posted
June 17, 2005
Study Start
January 1, 2006
Study Completion
April 1, 2007
Last Updated
January 4, 2013
Record last verified: 2013-01