Back to resultsAripiprazole in Patients With Acute Mania
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
About this trial
This is an interventional prevention trial for Bipolar Disorder focused on measuring Bipolar Mania
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of Acute Bipolar I Mania Exclusion Criteria: Patients with a DSM-IV diagnosis other than Bipolar I Mania
Sites / Locations
- Local Institution
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- Local Institition
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Outcomes
Primary Outcome Measures
Change from baseline to endpoint in a mania rating scale
Secondary Outcome Measures
Response rate and Clinical Global Impression scale at endpoint
Full Information
NCT ID
NCT00095511
First Posted
November 5, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00095511
Brief Title
Aripiprazole in Patients With Acute 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
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 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 trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
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
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
615 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in a mania rating scale
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:
Primary diagnosis of Acute Bipolar I Mania
Exclusion Criteria:
Patients with a DSM-IV diagnosis other than Bipolar I Mania
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
Scottsdale
State/Province
Arizona
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
La Palma
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
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Middletown
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
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
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Local Institition
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Saint Charles
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Elmsford
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Holliswood
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Morganton
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
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Lyndhurst
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Bellaire
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Arlington
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18835043
Citation
Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.
Results Reference
background
PubMed Identifier
22454801
Citation
McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.
Results Reference
derived
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Aripiprazole in Patients With Acute Mania
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