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

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Local Institution
    • California
      • La Mesa, California, United States
        • Local Institution
      • La Palma, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Redlands, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Sherman Oaks, California, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Coral Springs, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • St. Petersburg, Florida, United States
        • Local Institution
    • Georgia
      • Marietta, Georgia, United States
        • Local Institution
    • Illinois
      • Edwardsville, Illinois, United States
        • Local Institution
      • Oak Brook, Illinois, United States
        • Local Institution
      • Springfield, Illinois, United States
        • Local Institution
    • Indiana
      • Lafayette, Indiana, United States
        • Local Institution
    • Kansas
      • Newton, Kansas, United States
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, United States
        • Local Institution
      • Shreveport, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • Clementon, New Jersey, United States
        • Local Institution
    • New Mexico
      • Alburquerque, New Mexico, United States
        • Local Institution
    • New York
      • Brooklyn, New York, United States
        • Local Institution
      • Elmsford, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Raleigh, North Carolina, United States
        • Local Institution
    • Ohio
      • Dayton, Ohio, United States
        • Local Institution
    • Pennsylvania
      • Media, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Texas
      • Desoto, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
      • Wichita Falls, Texas, United States
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States
        • Local Institution
    • Virginia
      • Charlottesville, Virginia, United States
        • Local Institution
      • Midlothian, Virginia, United States
        • Local Institution
    • Washington
      • Bellevue, Washington, United States
        • Local Institution
    • West Virginia
      • Charleston, West Virginia, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Other Names:
  • Abilify
Placebo Comparator: A2
Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Clinical Global Impression - Bipolar Version
Severity of illness score depression
Mean change from baseline to endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

October 18, 2004

First Submitted That Met QC Criteria

October 18, 2004

First Posted (Estimate)

October 19, 2004

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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