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

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ClinicalTrials.gov Identifier: NCT00095524
Recruitment Status : Completed
First Posted : November 8, 2004
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Body Weight Change Schizophrenia Schizoaffective Disorder Psychotic Disorder Drug: Aripiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
Study Start Date : March 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine

Secondary Outcome Measures :
  1. Assessment of metabolic laboratory measures


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095524


Locations
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United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
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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
United States, Connecticut
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New Britain, Connecticut, United States
United States, Florida
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North Miami, Florida, United States
United States, Georgia
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Augusta, Georgia, United States
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Macon, Georgia, United States
United States, Illinois
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Hoffman Estates, Illinois, United States
United States, Kentucky
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Louisville, Kentucky, United States
United States, Maryland
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Glen Burnie, Maryland, United States
United States, Massachusetts
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Haverhill, Massachusetts, United States
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Worcester, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
United States, New York
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Brooklyn, New York, United States
United States, Tennessee
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Nashville, Tennessee, United States
United States, Texas
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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
United States, Wisconsin
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Wauwatosa, Wisconsin, United States
Brazil
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Goibnia, Goias, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil
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Botucatu, Sao Paulo, Brazil
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Sao Paulo - Sp, Sao Paulo, Brazil
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Rio De Janeiro, Brazil
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Sao Paulo, Brazil
United Kingdom
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Exeter, Devon, United Kingdom
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Birmingham, West Midlands, United Kingdom
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00095524    
Other Study ID Numbers: CN138-122
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: May 2008
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Patient weight change
changes in metabolic status
Additional relevant MeSH terms:
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Disease
Overweight
Body Weight
Body Weight Changes
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists