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

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00095524
First received: November 5, 2004
Last updated: November 7, 2013
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional 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
Study First Received: November 5, 2004
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Patient weight change
changes in metabolic status

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Disease
Mental Disorders
Overweight
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014