Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
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.
1 other identifier
interventional
120
1 country
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Jul 2006
Shorter than P25 for phase_3 schizophrenia
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 27, 2007
December 1, 2007
September 21, 2006
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline on body weight at the final evaluation.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Unknown Facility
Little Rock, Arkansas, 72201, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Anaheim, California, 92802, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Anaheim, California, 92805, United States
Unknown Facility
Boynton Beach, California, 33426, United States
Unknown Facility
Costa Mesa, California, 92363, United States
Unknown Facility
Costa Mesa, California, 92627, United States
Unknown Facility
Escondido, California, 92025, United States
Unknown Facility
Garden Grove, California, 92845, United States
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Glendale, California, 91206, United States
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Huntington Beach, California, 92648, United States
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La Mesa, California, 91942, United States
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National City, California, 91950, United States
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Oceanside, California, 92056, United States
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Paramount, California, 90723, United States
Unknown Facility
Rosemead, California, 91770, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Diego, California, 92126, United States
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Santa Ana, California, 92705, United States
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New Britain, Connecticut, 06050, United States
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New London, Connecticut, 06320, United States
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DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33319, United States
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Jacksonville, Florida, 32256, United States
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North Miami, Florida, 33161, United States
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St. Petersburg, Florida, 33711, United States
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Atlanta, Georgia, 30308, United States
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Augusta, Georgia, 30912, United States
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Marietta, Georgia, 30060, United States
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Coevr d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60631, United States
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Hoffman Estates, Illinois, 60194, United States
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Joliet, Illinois, 60077, United States
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Naperville, Illinois, 60540, United States
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Lake Charles, Louisiana, 70601, United States
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Gaithersburg, Maryland, 20877, United States
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Worcester, Massachusetts, 01605, United States
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Flowood, Mississippi, 39232, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63118, United States
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St Louis, Missouri, 63128, United States
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North Platte, Nebraska, 69101, United States
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Cherry Hill, New Jersey, 08002, United States
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Clementon, New Jersey, 08021, United States
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New York, New York, 10035, United States
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Rochester, New York, 14624, United States
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Staten Island, New York, 10312, United States
Unknown Facility
Butner, North Carolina, 27509, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27707, United States
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Morehead City, North Carolina, 28557, United States
Unknown Facility
Fargo, North Dakota, 58102, United States
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Cleveland, Ohio, 44109, United States
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Oklahoma City, Oklahoma, 73118, United States
Unknown Facility
Oklahoma City, Oklahoma, 73139, United States
Unknown Facility
Norristown, Pennsylvania, 19401, United States
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Philadelphia, Pennsylvania, 19149, United States
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Pittsburgh, Pennsylvania, 15108, United States
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Cordova, Tennessee, 38018, United States
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Memphis, Tennessee, 38105, United States
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Murfressboro, Tennessee, 37129, United States
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Nashville, Tennessee, 37212, United States
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Austin, Texas, 78756, United States
Unknown Facility
DeSoto, Texas, 75115, United States
Unknown Facility
Irving, Texas, 75062, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 25, 2006
Study Start
July 1, 2006
Study Completion
September 1, 2007
Last Updated
December 27, 2007
Record last verified: 2007-12