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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • India
      • Chennai, India
        • Local Institution
      • Delhi, India
        • Local Institution
      • Hyderabad, India
        • Local Institution
      • Lucknow, India
        • Local Institution
      • Mumbai, India
        • Local Institution
      • Vishakhapatnam, India
        • Local Institution
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Local Institution
  • United States
    • North Carolina
      • Durham, North Carolina, 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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients
  • Must sign informed consent prior to protocol-related procedures

Exclusion Criteria:

  • Women who are pregnant, trying to become pregnant, or nursing
  • Significant risk of committing suicide
  • Any serious unstable medical conditions

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, 5 - 30 mg, 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 (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Outcome Measure
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

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

December 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-149

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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