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

NCT ID: NCT00095524

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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Conditions

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Body Weight Change Schizophrenia Schizoaffective Disorder Psychotic Disorder

Keywords

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Patient weight change changes in metabolic status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Little Rock, Arkansas, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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National City, California, United States

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San Diego, California, United States

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New Britain, Connecticut, United States

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North Miami, Florida, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Hoffman Estates, Illinois, United States

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Louisville, Kentucky, United States

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Glen Burnie, Maryland, United States

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Haverhill, Massachusetts, United States

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Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Brooklyn, New York, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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San Antonio, Texas, United States

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Wauwatosa, Wisconsin, United States

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Goibnia, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Botucatu, São Paulo, Brazil

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Sao Paulo - Sp, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Exeter, Devon, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Countries

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Italy Spain United States Brazil United Kingdom

References

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Newcomer JW, Campos JA, Marcus RN, Breder C, Berman RM, Kerselaers W, L'italien GJ, Nys M, Carson WH, McQuade RD. A multicenter, randomized, double-blind study of the effects of aripiprazole in overweight subjects with schizophrenia or schizoaffective disorder switched from olanzapine. J Clin Psychiatry. 2008 Jul;69(7):1046-56. doi: 10.4088/jcp.v69n0702.

Reference Type DERIVED
PMID: 18605811 (View on PubMed)

Other Identifiers

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CN138-122

Identifier Type: -

Identifier Source: org_study_id