Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
NCT ID: NCT00080314
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
400 participants
INTERVENTIONAL
2004-01-31
2006-10-31
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
* Men and women, who have experienced a prior manic episode that required hospitalization, 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
Tuscaloosa, Alabama, United States
Local Institution
Little Rock, Arkansas, United States
Local Institution
San Diego, California, United States
Local Institution
Sherman Oaks, California, United States
Local Institution
Norwich, Connecticut, United States
Local Institution
West Haven, Connecticut, United States
Local Institution
Jacksonville, Florida, United States
Local Institution
Maitland, Florida, United States
Local Institution
Orlando, Florida, United States
Local Insstitution
Honolulu, Hawaii, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Lake Charles, Louisiana, United States
Local Institution
Rockville, Maryland, United States
Local Institution
Durham, North Carolina, United States
Local Institution
Raleigh, North Carolina, United States
Local Institution
Beachwood, Ohio, United States
Local Institution
Dayton, Ohio, United States
Local Institution
Oklahoma City, Oklahoma, United States
Local Institution
Portland, Oregon, United States
Local Institution
Media, Pennsylvania, United States
Local Institution
Memphis, Tennessee, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Lake Jackson, Texas, United States
Local Institution
Wichita Falls, Texas, United States
Local Institution
Arlington, Virginia, United States
Local Institution
Bellevue, Washington, United States
Countries
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Other Identifiers
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CN138-096
Identifier Type: -
Identifier Source: org_study_id