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NCT00095511 Clinical Trial

Aripiprazole in Patients With Acute Mania

Bipolar Disorder Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00095511
Other study ID # CN138-135
Secondary ID
Status Completed
Phase Phase 3
First received November 5, 2004
Last updated November 7, 2013
Start date June 2004
Est. completion date May 2007

Study information
Verified date May 2008
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 615
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria:

- Patients with a DSM-IV diagnosis other than Bipolar I Mania

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• aripiprazole

Locations
Country Name City State
United States Local Institution Arlington Virginia
United States Local Institution Augusta Georgia
United States Local Institution Austin Texas
United States Local Institution Bellaire Texas
United States Local Institution Bradenton Florida
United States Local Institution Cedarhurst New York
United States Local Institution Cerritos California
United States Local Institution Chicago Illinois
United States Local Institution Cincinnati Ohio
United States Local Institution Clementon New Jersey
United States Local Institution Cleveland Ohio
United States Local Institution Denver Colorado
United States Local Institution Elmsford New York
United States Local Institution Garden Grove California
United States Local Institution Hoffman Estates Illinois
United States Local Institution Holliswood New York
United States Local Institution Honolulu Hawaii
United States Local Institution Houston Texas
United States Local Institution Indianapolis Indiana
United States Local Institution Kissimmee Florida
United States Local Institution La Palma California
United States Local Institution Louisville Kentucky
United States Local Institution Lyndhurst Ohio
United States Local Institution Maitland Florida
United States Local Institution Middletown Connecticut
United States Local Institution Morganton North Carolina
United States Local Institution New Haven Connecticut
United States Local Institution New Orleans Louisiana
United States Local Institution Norristown Pennsylvania
United States Local Institution Oklahoma City Oklahoma
United States Local Institution Philadelphia Pennsylvania
United States Local Institution Raleigh North Carolina
United States Local Institution Riverside California
United States Local Institution Saint Charles Missouri
United States Local Institution San Diego California
United States Local Institution Scottsdale Arizona
United States Local Institition Shreveport Louisiana
United States Local Institution Tuscaloosa Alabama

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline to endpoint in a mania rating scale
Secondary Response rate and Clinical Global Impression scale at endpoint
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