Study of Aripiprazole in Patients With Acute Bipolar Mania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097266
Recruitment Status : Completed
First Posted : November 22, 2004
Last Update Posted : November 8, 2013
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Placebo Drug: Aripiprazole Drug: Haloperidol Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 615 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097266

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

Additional Information:
Publications: Identifier: NCT00097266     History of Changes
Other Study ID Numbers: CN138-162
First Posted: November 22, 2004    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: July 2010

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

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents