Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

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

A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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

  • Brazil
      • Rio De Janeiro, Brazil
        • Local Institution
      • Sao Paulo, Brazil
        • Local Institution
    • Goias
      • Goibnia, Goias, Brazil
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Local Institution
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil
        • Local Institution
      • Sao Paulo - Sp, Sao Paulo, Brazil
        • Local Institution
  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Anaheim, California, United States
        • Local Institution
      • Cerritos, California, United States
        • Local Institution
      • Garden Grove, California, United States
        • Local Institution
      • National City, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
    • Connecticut
      • New Britain, Connecticut, United States
        • Local Institution
    • Florida
      • North Miami, Florida, United States
        • Local Institution
    • Georgia
      • Augusta, Georgia, United States
        • Local Institution
      • Macon, Georgia, United States
        • Local Institution
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Maryland
      • Glen Burnie, Maryland, United States
        • Local Institution
    • Massachusetts
      • Haverhill, Massachusetts, United States
        • Local Institution
      • Worcester, Massachusetts, United States
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Local Institution
    • New York
      • Brooklyn, New York, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
      • DeSoto, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Wisconsin
      • Wauwatosa, Wisconsin, 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:

  • Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

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
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine

Secondary Outcome Measures

Outcome Measure
Assessment of metabolic laboratory measures

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

March 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

November 5, 2004

First Submitted That Met QC Criteria

November 5, 2004

First Posted (Estimate)

November 8, 2004

Study Record Updates

Last Update Posted (Estimate)

November 11, 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

  • CN138-122

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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