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

January 3, 2013 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
    • Idaho
      • Eagle, Idaho, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Moorestown, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Research Triangle Park, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Media, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Wichita Falls, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Kirkland, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 16, 2005

First Submitted That Met QC Criteria

June 16, 2005

First Posted (Estimate)

June 17, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D144AL00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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