Study of Aripiprazole in Patients With Acute Bipolar Mania

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: November 19, 2004
Last updated: November 7, 2013
Last verified: July 2010
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.

Condition Intervention Phase
Bipolar Disorder
Drug: Placebo
Drug: Aripiprazole
Drug: Haloperidol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Change in a mania rating scale at endpoint

Secondary Outcome Measures:
  • Response rate and Clinical Global Impression scale at endpoint

Estimated Enrollment: 615
Study Start Date: December 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Placebo
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
Experimental: B Drug: Aripiprazole
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Other Name: Abilify
Active Comparator: C Drug: Haloperidol
Capsule, oral, 5-15 mg, once daily, 12 weeks.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00097266

  Show 45 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications: Identifier: NCT00097266     History of Changes
Other Study ID Numbers: CN138-162 
Study First Received: November 19, 2004
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar Mania

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on April 27, 2016