Study of Aripiprazole in Patients With Bipolar I Disorder

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

Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

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

  • Australia
    • Victoria
      • Epping, Victoria, Australia
        • Local Institution
  • Bulgaria
      • Rousse, Bulgaria
        • Local Institution
      • Sofia, Bulgaria
        • Local Institution
      • Varna, Bulgaria
        • Local Institution
  • Czech Republic
      • Brno - Bohunice, Czech Republic
        • Local Institution
      • Hradec Kralove, Czech Republic
        • Local Institution
      • Opava, Czech Republic
        • Local Institution
      • Praha 2, Czech Republic
        • Local Institution
  • Estonia
      • Parnu, Estonia
        • Local Institution
      • Tallinn, Estonia
        • Local Institution
      • Tartu, Estonia
        • Local Institution
      • Viljandi Maakond, Estonia
        • Local Institution
      • Voru Maakond, Estonia
        • Local Institution
  • France
      • Bordeaux, France
        • Local Institution
      • Dole, France
        • Local Institution
      • Grenoble, France
        • Local Institution
      • Jonzac Cedex, France
        • Local Institution
      • La Rochelle Cedex 1, France
        • Local Institution
      • Limoges Cedex, France
        • Local Institution
      • Marseille Cedex 05, France
        • Local Institution
      • Nimes, France
        • Local Institution
      • Pessac, France
        • Local Institution
      • Rennes Cedex, France
        • Local Institution
  • Germany
      • Berlin, Germany
        • Local Institution
      • Jena, Germany
        • Local Institution
      • Magdeburg, Germany
        • Local Institution
      • Meunchen, Germany
        • Local Institution
      • Westersted, Germany
        • Local Institution
  • Hungary
      • Budapest, Hungary
        • Local Institution
      • Gyula, Hungary
        • Local Institution
      • Kecskemet, Hungary
        • Local Institution
      • Nagykallo, Hungary
        • Local Institution
  • Italy
      • Bassano Del Grappa, Italy
        • Local Institution
      • Cagliari, Italy
        • Local Institution
      • Firenze, Italy
        • Local Institution
      • Pisa, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
      • Sassari, Italy
        • Local Institution
      • Trieste, Italy
        • Local Institution
      • Voghera -Pavia, Italy
        • Local Institution
  • Netherlands
      • Retranchement, Netherlands
        • Local Institution
      • Zaandam, Netherlands
        • Local Institution
  • Poland
      • Choroszcz, Poland
        • Local Institution
      • Koscian, Poland
        • Local Institution
      • Krakow, Poland
        • Local Institution
      • Poznan, Poland
        • Local Institution
      • Torun, Poland
        • Local Institution
      • Tuszyn, Poland
        • Local Institution
  • Portugal
      • Lisboa, Portugal
        • Local Institution
      • Lisbon, Portugal
        • Local Institution
  • Russian Federation
      • Leningrad Region, Russian Federation
        • Local Institution
      • Moscow, Russian Federation
        • Local Institution
      • Saint Petersburg, Russian Federation
        • Local Institution
      • Smolensk, Russian Federation
        • Local Institution
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa
        • Local Institution
    • Free State
      • Westdene, Free State, South Africa
        • Local Institution
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • Local Institution
      • Vereeniging, Gauteng, South Africa
        • Local Institution
      • Welkom, Gauteng, South Africa
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, South Africa
        • Local Institution
    • Western Cape
      • Observatory, Western Cape, South Africa
        • Local Institution
  • Spain
      • Barcelona, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Valencia, Spain
        • Local Institution
      • Vitoria, Spain
        • Local Institution
  • Switzerland
      • Herisau, Switzerland
        • Local Institution
  • United Kingdom
    • Dumbartonshire
      • Glasgow, Dumbartonshire, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
    • Lancashire
      • Burnley, Lancashire, United Kingdom
        • Local Institution
    • Mid Glamorgan
      • South Wales, Mid Glamorgan, United Kingdom
        • Local Institution
    • Middlesex
      • Surbiton, Middlesex, United Kingdom
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Riverside, California, United States
        • Local Institution
    • Florida
      • Deerfield Beach, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Maitland, Florida, United States
        • Local Institution
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Local Institution
      • Oakbrook, Illinois, United States
        • Local Institution
    • Kansas
      • Newton, Kansas, United States
        • Local Institution
    • Massachusetts
      • Newton, Massachusetts, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
      • Staten Island, 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
      • Norristown, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Tennessee
      • Memphis, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
    • Washington
      • Bellevue, Washington, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion Criteria:

  • First manic or mixed episode
  • Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
  • Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to endpoint in a mania rating scale

Secondary Outcome Measures

Outcome Measure
Response rate and Clinical Global Impression Scale at 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-134

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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