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

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ClinicalTrials.gov Identifier: NCT00094432
Recruitment Status : Completed
First Posted : October 19, 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 several doses of aripiprazole in patients with bipolar depression.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 650 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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
Study Start Date : June 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. Mean change from baseline to endpoint on the MADRS total score.

Secondary Outcome Measures :
  1. Clinical Global Impression - Bipolar Version
  2. Severity of illness score depression
  3. Mean change from baseline to endpoint


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 18-65
  • Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, 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): NCT00094432


  Show 40 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00094432     History of Changes
Other Study ID Numbers: CN138-146
First Posted: October 19, 2004    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: June 2008

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

Additional relevant MeSH terms:
Disease
Depressive Disorder, Major
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs