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
447 participants
INTERVENTIONAL
2007-01-31
2007-07-31
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 Disorder, with most recent episode being manic or mixed
* Inpatient hospital admission for the first 4 days of study treatment
Exclusion Criteria
* Use of prohibited medication
* 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
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Cerritos, California, United States
Research Site
Garden Grove, California, United States
Research Site
Oceanside, California, United States
Research Site
Pico Rivera, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Ana, California, United States
Research Site
Torrance, California, United States
Research Site
Denver, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Aventura, Florida, United States
Research Site
EAST Bradenton, Florida, United States
Research Sitew
Fort Lauderdale, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Leesburg, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Hoffman Estates, Illinois, United States
Research Site
Naperville, Illinois, United States
Research Site
OAK Brook Terrace, Illinois, United States
Research Site
Greenwood, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Newton, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Lake Charles, Louisiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Rockville, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Kenilworth, New Jersey, United States
Research Site
Willingboro, New Jersey, United States
Research Site
Elmsford, New York, United States
Research Site
Holliswood, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Beachwood, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Moon Township, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
DeSoto, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Irving, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Arlington, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Bellevue, Washington, United States
Countries
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References
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Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.
Other Identifiers
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D144CC00004
Identifier Type: -
Identifier Source: org_study_id
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