Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

NCT ID: NCT00114686

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Bipolar I Disorder Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine fumarate

Intervention Type DRUG

lithium

Intervention Type DRUG

divalproex

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States

Other Identifiers

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D144AL00002

Identifier Type: -

Identifier Source: org_study_id

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