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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095524
First Posted: November 8, 2004
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.

Condition Intervention Phase
Body Weight Change Schizophrenia Schizoaffective Disorder Psychotic Disorder Drug: Aripiprazole Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

Secondary Outcome Measures:
  • Assessment of metabolic laboratory measures

Estimated Enrollment: 300
Study Start Date: March 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: November 5, 2004
First Posted: November 8, 2004
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