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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

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

U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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


  Show 32 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00095524     History of Changes
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:
Disease
Schizophrenia
Overweight
Psychotic Disorders
Body Weight
Mental Disorders
Body Weight Changes
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Signs and Symptoms
Aripiprazole
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents