Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
NCT ID: NCT00081380
Last Updated: 2008-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
710 participants
INTERVENTIONAL
2004-03-31
2006-09-30
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Seroquel®, quetiapine fumarate (atypical antipsychotic)
lithium (mood stabilizer)
divalproex (mood stabilizer)
Eligibility Criteria
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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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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
Countries
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References
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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.
Other Identifiers
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D1447C00127
Identifier Type: -
Identifier Source: org_study_id