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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00094432
First Posted: October 19, 2004
Last Update Posted: November 11, 2013
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.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean change from baseline to endpoint on the MADRS total score.

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

Estimated Enrollment: 650
Study Start Date: June 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.


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.
  Contacts and Locations
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00094432     History of Changes
Other Study ID Numbers: CN138-146
First Submitted: October 18, 2004
First Posted: October 19, 2004
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