Clinical trial NCT00095524: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Weight Change
Schizophrenia
Schizoaffective Disorder
Psychotic Disorder
Keywords: Patient weight change
changes in metabolic status
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

Primary outcomes:
measure: Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
Secondary outcomes:
measure: Assessment of metabolic laboratory measures
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Anaheim
country: United States
facility: Local Institution
state: California
city: Cerritos
country: United States
facility: Local Institution
state: California
city: Garden Grove
country: United States
facility: Local Institution
state: California
city: National City
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: New Britain
country: United States
facility: Local Institution
state: Connecticut
city: North Miami
country: United States
facility: Local Institution
state: Florida
city: Augusta
country: United States
facility: Local Institution
state: Georgia
city: Macon
country: United States
facility: Local Institution
state: Georgia
city: Hoffman Estates
country: United States
facility: Local Institution
state: Illinois
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Glen Burnie
country: United States
facility: Local Institution
state: Maryland
city: Haverhill
country: United States
facility: Local Institution
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution
state: Massachusetts
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: DeSoto
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Wauwatosa
country: United States
facility: Local Institution
state: Wisconsin
city: Goibnia
country: Brazil
facility: Local Institution
state: Goias
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo - Sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Exeter
country: United Kingdom
facility: Local Institution
state: Devon
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.