Phase III/Seroquel SR Bipolar Depression Monotherapy - US
NCT ID: NCT00422214
Last Updated: 2009-03-25
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
400 participants
INTERVENTIONAL
2006-12-31
2007-06-30
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine fumarate (Seroquel) SR
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
* Outpatient status at enrollment
Exclusion Criteria
* Use of prohibited medications
* Substance or alcohol abuse or dependence
* Current suicide risk or suicide attempt within last 6 months.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Catherine Datto, MD
Role: STUDY_DIRECTOR
AstraZeneca
Larisa Acevedo, Ph.D
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
Research Site
Little Rock, Arkansas, United States
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Cerritos, California, United States
Research Site
La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Wildomar, California, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Smyrna, Georgia, United States
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Honolulu, Hawaii, United States
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Joliet, Illinois, 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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Shreveport, Louisiana, United States
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Rockville, Maryland, United States
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Farmington Hills, Michigan, United States
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St Louis, Missouri, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, 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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Staten Island, New York, 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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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, 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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Dallas, Texas, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
South Kirkland, Washington, United States
Countries
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Other Identifiers
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D144CC00002
Identifier Type: -
Identifier Source: org_study_id
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