Clinical trial NCT00380224: Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 120
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: This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

Detailed description: This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Eligibility criteria: Inclusion criteria:

* Current treatment of at least 3 months with olanzapine.
* Primary diagnosis of schizophrenia.
* Total Positive and Negative Symptoms Scale (PANSS) score \<=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: Change from baseline on body weight at the final evaluation.
Secondary outcomes:
measure: 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.
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: New Britain
country: United States
state: Connecticut
city: New London
country: United States
state: Connecticut
city: Deland
country: United States
state: Florida
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: 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: 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: New York
country: United States
state: New York
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: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
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: Murfressboro
country: United States
state: Tennessee
city: Nashville
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
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: