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Sponsors and Collaborators: |
Bristol-Myers Squibb Otsuka America Pharmaceutical |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00095524 |
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.
Condition | Intervention | Phase |
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Body Weight Change Schizophrenia Schizoaffective Disorder Psychotic Disorder |
Drug: Aripiprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder |
Estimated Enrollment: | 300 |
Study Start Date: | March 2004 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | CN138-122 |
Study First Received: | November 5, 2004 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00095524 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Patient weight change changes in metabolic status |
Tranquilizing Agents Psychotropic Drugs Olanzapine Central Nervous System Depressants Overweight Antipsychotic Agents Body Weight |
Schizophrenia Signs and Symptoms Mental Disorders Body Weight Changes Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Body Weight Schizophrenia |
Signs and Symptoms Pathologic Processes Mental Disorders Therapeutic Uses Body Weight Changes Psychotic Disorders Aripiprazole Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |