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

March 24, 2009 updated by: AstraZeneca

A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) 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

  • Australia
    • New South Wales
      • Greenwich, New South Wales, Australia
        • Research Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site
      • Everton Park, Queensland, Australia
        • Research Site
      • Southport, Queensland, Australia
        • Research Site
    • South Australia
      • Glenside, South Australia, Australia
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Research Site
      • Dandenong, Victoria, Australia
        • Research Site
      • Epping, Victoria, Australia
        • Research Site
      • Richmond, Victoria, Australia
        • Research Site
  • Belgium
      • Assebroek, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Kortenberg, Belgium
        • Research Site
      • Manage, Belgium
        • Research Site
      • St-Denijs-Westrem, Belgium
        • Research Site
      • Waregem, Belgium
        • Research Site
  • Bulgaria
      • Kardjali, Bulgaria
        • Research Site
      • Rousse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Czech Republic
      • Jeseník, Czech Republic
        • Research Site
      • Litomolice, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Praha 10, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Praha 8, Czech Republic
        • Research Site
      • Pterova, Czech Republic
        • Research Site
  • Finland
      • Espoo, Finland
        • Research Site
      • Harjavalta, Finland
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Kellokoski, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
  • France
      • Besancon, France
        • Research Site
      • Bourg En Bresse, France
        • Research Site
      • La Rochelle Cedex 1, France
        • Research Site
      • Marseille Cedex 9, France
        • Research Site
      • Montpellier, France
        • Research Site
      • NIMES Cedex 4, France
        • Research Site
      • Paris Cedex 12, France
        • Research Site
      • Strasbourg Cedex, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Saarbrucken, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Fuzesabony, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Kistarcsa, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Bergamo, Italy
        • Research Site
      • Brescia, Italy
        • Research Site
      • Cagliari, Italy
        • Research Site
      • Civitanova Marche, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • La Spezia, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Trieste, Italy
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Bodo, Norway
        • Research Site
      • Bryne, Norway
        • Research Site
      • Namsos, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Ottestad, Norway
        • Research Site
      • Skien, Norway
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Choroszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gorlice, Poland
        • Research Site
      • Janów Lubelski, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lipno, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Nowy Targ, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Starogard Gdanski, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Zubki, Poland
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Krugersdorp, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Bilbao, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Guadalajara, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Santiago de Compostela, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Vigo, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
      • Sama de Langreo, Asturias, Spain
        • Research Site
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Research Site
    • Cádiz
      • Puerto Real, Cádiz, Spain
        • Research Site
  • Sweden
      • Falkoping, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Ludvika, Sweden
        • Research Site
      • Sollentuna, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Sundsvall, Sweden
        • Research Site
  • Turkey
      • Adana, Turkey
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Runcorn, United Kingdom
        • Research Site
      • Ryhope, United Kingdom
        • Research Site
      • Surbiton, United Kingdom
        • Research Site
      • Welwyn Garden City, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Beverly Hills, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Redlands, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
    • Florida
      • Gainesville, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Illinois
      • Granite City, Illinois, United States
        • Research Site
      • Libertyville, Illinois, United States
        • Research Site
      • Schaumburg, Illinois, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
    • Missouri
      • St. Charles, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • Olean, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Morganton, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Havertown, Pennsylvania, United States
        • Research Site
      • Media, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Conroe, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

  • 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 Assignment
  • 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

April 1, 2004

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

April 7, 2005

First Submitted That Met QC Criteria

April 7, 2005

First Posted (Estimate)

April 8, 2005

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1447C00126

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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