Clinical trial NCT00366704: Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
Official title: A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone in the Treatment of Outpatients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-08-21
Enrollment: 400
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 purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.


Eligibility criteria: Inclusion criteria:

* Current treatment of at least 3 months with risperidone.
* Primary diagnosis of schizophrenia.
* Total Positive and Negative Symptoms Scale (PANSS) score \< or = 70 at screening and baseline.

Exclusion criteria:

* Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
* History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
* History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.

Primary outcomes:
measure: The primary analysis will be the change from baseline on body weight at the final evaluation.
timeFrame: 8 weeks
Secondary outcomes:
measure: Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Boynton Beach
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Escondido
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: La Mesa
country: United States
state: California
city: National City
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Paramount
country: United States
state: California
city: Rosemead
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: New London
country: United States
state: Connecticut
city: Ft. Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Coevr d'Alene
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Gaithersburg
country: United States
state: Maryland
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: North Platte
country: United States
state: Nebraska
city: Cherry Hill
country: United States
state: New Jersey
city: Clementon
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Butner
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: East Stroudsberg
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Cordova
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: DeSoto
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: