Back to resultsEfficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Primary Purpose
Bipolar I Disorder, Alcohol Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine fumarate
lithium
divalproex
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Disorder focused on measuring Bipolar I Disorder, Alcohol Dependency
Eligibility Criteria
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
Sites / Locations
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Outcomes
Primary Outcome Measures
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00114686
Brief Title
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder, Alcohol Dependence
Keywords
Bipolar I Disorder, Alcohol Dependency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
350 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
lithium
Intervention Type
Drug
Intervention Name(s)
divalproex
Primary Outcome Measure Information:
Title
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Secondary Outcome Measure Information:
Title
Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Title
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
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City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Eagle
State/Province
Idaho
Country
United States
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City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
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City
Glen Burnie
State/Province
Maryland
Country
United States
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Boston
State/Province
Massachusetts
Country
United States
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St. Louis
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Missouri
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United States
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City
Moorestown
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New Jersey
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United States
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Albuquerque
State/Province
New Mexico
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United States
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Bronx
State/Province
New York
Country
United States
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City
New York
State/Province
New York
Country
United States
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City
Staten Island
State/Province
New York
Country
United States
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City
Chapel Hill
State/Province
North Carolina
Country
United States
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City
Research Triangle Park
State/Province
North Carolina
Country
United States
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Cincinnati
State/Province
Ohio
Country
United States
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Cleveland
State/Province
Ohio
Country
United States
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Dayton
State/Province
Ohio
Country
United States
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Portland
State/Province
Oregon
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United States
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Media
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Pennsylvania
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United States
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Philadelphia
State/Province
Pennsylvania
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United States
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Pittsburgh
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Pennsylvania
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United States
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Columbia
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South Carolina
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United States
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Memphis
State/Province
Tennessee
Country
United States
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City
Nashville
State/Province
Tennessee
Country
United States
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City
Austin
State/Province
Texas
Country
United States
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Dallas
State/Province
Texas
Country
United States
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Houston
State/Province
Texas
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United States
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San Antonio
State/Province
Texas
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United States
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Wichita Falls
State/Province
Texas
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United States
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Richmond
State/Province
Virginia
Country
United States
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Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
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Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
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