Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Phase 3
Completed
- Conditions
- Bipolar I DisorderAlcohol Dependence
- Registration Number
- NCT00114686
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
- Meets criteria for Bipolar I Disorder with Alcohol dependence
- Outpatient Status
- Recent history of heavy drinking
Exclusion Criteria
- Unstable medical illness
- Recent antipsychotic use
- Poorly controlled Diabetes Mellitus or Diabetes related illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Milwaukee, Wisconsin, United States