Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

January 3, 2013 updated by: AstraZeneca

A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

530

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
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • California
      • Cerritos, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Illinois
      • Oak Brook, Illinois, United States
        • Research Site
      • Overbrook Terrace, Illinois, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • New Jersey
      • Clementon, New Jersey, United States
        • Research Site
      • Moorestown, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, 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
      • Houston, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Kirkland, Washington, United States
        • Research Site
      • Seattle, Washington, 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria:

  • More than 8 mood episodes in the past year from screen (visit 1);
  • A current Axis I disorder other than bipolar disorder within 6 months of screening;
  • patients with clinically significant abnormal laboratory findings in the investigator's judgment

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Outcome Measure
Evaluate the incidence of treatment-emergent mania compared to placebo

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

June 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

June 3, 2004

First Submitted That Met QC Criteria

June 4, 2004

First Posted (Estimate)

June 7, 2004

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

  • D1447C00135

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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