Aripiprazole in Patients With Acute Mania

NCT ID: NCT00095511

Last Updated: 2013-11-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar Mania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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aripiprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria

* Patients with a DSM-IV diagnosis other than Bipolar I Mania
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

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

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Scottsdale, Arizona, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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La Palma, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Middletown, Connecticut, United States

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New Haven, Connecticut, United States

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Bradenton, Florida, United States

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Kissimmee, Florida, United States

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Maitland, Florida, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Saint Charles, Missouri, United States

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Clementon, New Jersey, United States

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Cedarhurst, New York, United States

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Elmsford, New York, United States

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Holliswood, New York, United States

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Morganton, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Houston, Texas, United States

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Arlington, Virginia, United States

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Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18835043 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22454801 (View on PubMed)

Other Identifiers

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CN138-135

Identifier Type: -

Identifier Source: org_study_id