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NCT00095524 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00095524
Other study ID # CN138-122
Secondary ID
Status Completed
Phase Phase 3
First received November 5, 2004
Last updated November 7, 2013
Start date March 2004
Est. completion date August 2006

Study information
Verified date May 2008
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole

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

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical

Countries where clinical trial is conducted

United States,  Brazil,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
Secondary Assessment of metabolic laboratory measures
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