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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.
 
ClinicalTrials.gov Identifier: NCT00097266
Recruitment Status : Completed
First Posted : November 22, 2004
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
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

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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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00097266


Locations
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United States, California
Local Institution
Anaheim, California, United States
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Cerritos, California, United States
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Garden Grove, California, United States
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National City, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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San Diego, California, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Maitland, Florida, United States
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Tampa, Florida, United States
United States, Louisiana
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Shreveport, Louisiana, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, Ohio
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Cleveland, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Texas
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Desoto, Texas, United States
Bulgaria
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Burgas, Bulgaria
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Novi Iskar, Bulgaria
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Pleven, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Split, Croatia
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Zagreb, Croatia
Mexico
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Mexico, Distrito Federal, Mexico
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Zapopan, Jalisco, Mexico
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Col. Obispado, Nuevo Leon, Mexico
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Monterrey, Nuevo Leon, Mexico
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Fracc. Industrias, San Luis Potosi, Mexico
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Merida, Yucatan, Mexico
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Nuevo Leon, Mexico
Peru
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Lima, Peru
Russian Federation
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Lipetsk, Lipetsk Region, Russian Federation
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Arkhangelsk, Russian Federation
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Kazan, Russian Federation
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Leningrad Region, Russian Federation
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Moscow, Russian Federation
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Nizhniy Novgorod, Russian Federation
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Samara, Russian Federation
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St. Petersburg, Russian Federation
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Volgograd, Russian Federation
South Africa
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Florida, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, Kwa Zulu Natal, South Africa
Local Institution
Berea, Kwa Zuluu Natal, South Africa
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Publications:
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ClinicalTrials.gov Identifier: NCT00097266    
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:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Haloperidol
Aripiprazole
Haloperidol decanoate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents