Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

December 19, 2008 updated by: AstraZeneca

Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

710

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

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • Markham, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Oshawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Cerritos, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Culver City, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • La Mesa, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • Pico Rivera, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Rosemead, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
    • Connecticut
      • Farmington, Connecticut, United States
        • Research Site
      • New Britain, Connecticut, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Smyrna, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Hoffman Estates, Illinois, United States
        • Research Site
      • Joliet, Illinois, United States
        • Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Research Site
      • Greenwood, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Florence, Kentucky, United States
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Rockville, Maryland, United States
        • Research Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Michigan
      • New Baltimore, Michigan, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Clementon, New Jersey, United States
        • Research Site
      • Moorestown, New Jersey, United States
        • Research Site
      • West Caldwell, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Butner, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Medina, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
      • Tulsa, Oklahoma, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Emmaus, Pennsylvania, United States
        • Research Site
      • Moon Township, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • DeSoto, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Wichita Falls, Texas, United States
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Site
      • Falls Church, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
      • Virginia Beach, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Kirkland, Washington, United States
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Open-Label

  • A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
  • At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
  • Able to understand and comply with the requirements of the study.

Exclusion Criteria:

Open-Label

  • Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
  • Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
  • Previously randomized into this study or D1447C00126

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.

Secondary Outcome Measures

Outcome Measure
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2004

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

April 9, 2004

First Submitted That Met QC Criteria

April 16, 2004

First Posted (ESTIMATE)

April 19, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2008

Last Update Submitted That Met QC Criteria

December 19, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1447C00127

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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