Back to resultsStudy of Aripiprazole in Patients With Acute Bipolar Mania
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Aripiprazole
Haloperidol
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Mania
Eligibility Criteria
Inclusion Criteria: Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Change in a mania rating scale at endpoint
Secondary Outcome Measures
Response rate and Clinical Global Impression scale at endpoint
Full Information
NCT ID
NCT00097266
First Posted
November 19, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00097266
Brief Title
Study of Aripiprazole in Patients With Acute Bipolar Mania
Official Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (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 research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Mania
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
615 (false)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Capsule, oral, 5-15 mg, once daily, 12 weeks.
Primary Outcome Measure Information:
Title
Change in a mania 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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
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
Anaheim
State/Province
California
Country
United States
Facility Name
Local Institution
City
Cerritos
State/Province
California
Country
United States
Facility Name
Local Institution
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Local Institution
City
National City
State/Province
California
Country
United States
Facility Name
Local Institution
City
Pico Rivera
State/Province
California
Country
United States
Facility Name
Local Institution
City
Riverside
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Local Institution
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Desoto
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Burgas
Country
Bulgaria
Facility Name
Local Institution
City
Novi Iskar
Country
Bulgaria
Facility Name
Local Institution
City
Pleven
Country
Bulgaria
Facility Name
Local Institution
City
Sofia
Country
Bulgaria
Facility Name
Local Institution
City
Varna
Country
Bulgaria
Facility Name
Local Institution
City
Osijek
Country
Croatia
Facility Name
Local Institution
City
Rijeka
Country
Croatia
Facility Name
Local Institution
City
Split
Country
Croatia
Facility Name
Local Institution
City
Zagreb
Country
Croatia
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Local Institution
City
Col. Obispado
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Local Institution
City
Fracc. Industrias
State/Province
San Luis Potosi
Country
Mexico
Facility Name
Local Institution
City
Merida
State/Province
Yucatan
Country
Mexico
Facility Name
Local Institution
City
Nuevo Leon
Country
Mexico
Facility Name
Local Institution
City
Lima
Country
Peru
Facility Name
Local Institution
City
Lipetsk
State/Province
Lipetsk Region
Country
Russian Federation
Facility Name
Local Institution
City
Arkhangelsk
Country
Russian Federation
Facility Name
Local Institution
City
Kazan
Country
Russian Federation
Facility Name
Local Institution
City
Leningrad Region
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Local Institution
City
Samara
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Volgograd
Country
Russian Federation
Facility Name
Local Institution
City
Florida
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Local Institution
City
Berea
State/Province
Kwa Zuluu Natal
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
19118324
Citation
Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.
Results Reference
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Learn more about this trial
Study of Aripiprazole in Patients With Acute Bipolar Mania
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