Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
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)
1 other identifier
interventional
710
2 countries
94
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2004
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 9, 2004
CompletedFirst Posted
Study publicly available on registry
April 19, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 22, 2008
December 1, 2008
April 9, 2004
December 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (94)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Cerritos, California, United States
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Chula Vista, California, United States
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Culver City, California, United States
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Garden Grove, California, United States
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La Mesa, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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Rosemead, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Farmington, Connecticut, United States
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New Britain, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Smyrna, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Joliet, Illinois, United States
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Evansville, Indiana, United States
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Greenwood, Indiana, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Florence, Kentucky, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Pittsfield, Massachusetts, United States
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New Baltimore, Michigan, United States
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St Louis, Missouri, United States
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Clementon, New Jersey, United States
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Moorestown, New Jersey, United States
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West Caldwell, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Butner, North Carolina, United States
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Raleigh, North Carolina, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Medina, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Emmaus, Pennsylvania, United States
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Moon Township, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Irving, 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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Charlottesville, Virginia, United States
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Falls Church, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Morgantown, West Virginia, United States
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Related Publications (1)
Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
PMID: 23761037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 9, 2004
First Posted
April 19, 2004
Study Start
March 1, 2004
Study Completion
September 1, 2006
Last Updated
December 22, 2008
Record last verified: 2008-12