Back to resultsStudy of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar 1 Disorder, depressed
Eligibility Criteria
ages 18-65 Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.
Sites / Locations
- Local Institution
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- Local Insstitution
- Local Institution
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- Local Institution
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- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A1
A2
Arm Description
Outcomes
Primary Outcome Measures
Change on a depression rating scale at endpoint
Secondary Outcome Measures
Response rate and Clinical Global Impression scale at endpoint
Full Information
NCT ID
NCT00080314
First Posted
March 26, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00080314
Brief Title
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar 1 Disorder, depressed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, Once daily, 8 weeks.
Primary Outcome Measure Information:
Title
Change on a depression rating scale at endpoint
Secondary Outcome Measure Information:
Title
Response rate and Clinical Global Impression scale at endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
ages 18-65
Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Sherman Oaks
State/Province
California
Country
United States
Facility Name
Local Institution
City
Norwich
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
West Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Local Insstitution
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Media
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Lake Jackson
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Wichita Falls
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Bellevue
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
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