Back to resultsEffects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
Primary Purpose
Body Weight Change, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Body Weight Change focused on measuring Patient weight change, changes in metabolic status
Eligibility Criteria
Inclusion Criteria: Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Sites / Locations
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
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
Full Information
NCT ID
NCT00095524
First Posted
November 5, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00095524
Brief Title
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Change, Schizophrenia, Schizoaffective Disorder, Psychotic Disorder
Keywords
Patient weight change, changes in metabolic status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
Secondary Outcome Measure Information:
Title
Assessment of metabolic laboratory measures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
Anaheim
State/Province
California
Country
United States
Facility Name
Local Institution
City
Cerritos
State/Province
California
Country
United States
Facility Name
Local Institution
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Local Institution
City
National City
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Local Institution
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
DeSoto
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Wauwatosa
State/Province
Wisconsin
Country
United States
Facility Name
Local Institution
City
Goibnia
State/Province
Goias
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Local Institution
City
Botucatu
State/Province
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo - Sp
State/Province
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Exeter
State/Province
Devon
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18605811
Citation
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. doi: 10.4088/jcp.v69n0702.
Results Reference
derived
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Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
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