Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
NCT00366704
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint | |||
Official Title ICMJE | 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. | |||
Brief Summary | The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Schizophrenia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Estimated Enrollment ICMJE | 400 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00366704 | |||
Other Study ID Numbers ICMJE | 3168A1-313 B3101009 ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Solvay Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |