A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
NCT ID: NCT00094432
Last Updated: 2013-11-11
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
650 participants
INTERVENTIONAL
2004-06-30
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
A2
Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.
Interventions
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Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Mesa, Arizona, United States
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La Mesa, California, United States
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La Palma, California, United States
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Long Beach, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Washington D.C., District of Columbia, United States
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Coral Springs, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Marietta, Georgia, United States
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Edwardsville, Illinois, United States
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Oak Brook, Illinois, United States
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Springfield, Illinois, United States
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Lafayette, Indiana, United States
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Newton, Kansas, 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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St Louis, Missouri, United States
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Clementon, 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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Elmsford, New York, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Dayton, Ohio, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Midlothian, Virginia, United States
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Bellevue, Washington, United States
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Charleston, West Virginia, United States
Countries
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Other Identifiers
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CN138-146
Identifier Type: -
Identifier Source: org_study_id