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

This study has been completed.

First Received: November 5, 2004 Last Updated: May 21, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00095524

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 III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Aripiprazole Olanzapine

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095524

Show 33 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Newcomer JW, Campos JA, Marcus RN, Breder C, Berman RM, Kerselaers W, L'italien GJ, Nys M, Carson WH, McQuade RD. A multicenter, randomized, double-blind study of the effects of aripiprazole in overweight subjects with schizophrenia or schizoaffective disorder switched from olanzapine. J Clin Psychiatry. 2008 Jul;69(7):1046-56.

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

Keywords provided by Bristol-Myers Squibb:

Patient weight change
changes in metabolic status

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009