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Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

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: NCT00080314
Recruitment Status : Completed
First Posted : March 30, 2004
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
Study Start Date : January 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A1 Drug: Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Other Name: Abilify

Placebo Comparator: A2 Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.




Primary Outcome Measures :
  1. Change on a depression 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 to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • ages 18-65
  • Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

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): NCT00080314


Locations
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United States, Alabama
Local Institution
Tuscaloosa, Alabama, United States
United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
Local Institution
San Diego, California, United States
Local Institution
Sherman Oaks, California, United States
United States, Connecticut
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Norwich, Connecticut, United States
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West Haven, Connecticut, United States
United States, Florida
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Orlando, Florida, United States
United States, Hawaii
Local Insstitution
Honolulu, Hawaii, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Louisiana
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Lake Charles, Louisiana, United States
United States, Maryland
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Rockville, Maryland, United States
United States, North Carolina
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
United States, Ohio
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Beachwood, Ohio, United States
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Dayton, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
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Media, Pennsylvania, United States
United States, Tennessee
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Memphis, Tennessee, United States
United States, Texas
Local Institution
Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Wichita Falls, Texas, United States
United States, Virginia
Local Institution
Arlington, Virginia, United States
United States, Washington
Local Institution
Bellevue, Washington, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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ClinicalTrials.gov Identifier: NCT00080314    
Other Study ID Numbers: CN138-096
First Posted: March 30, 2004    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: June 2008
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar 1 Disorder, depressed
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
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