Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
NCT00396214
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- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
- Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric
diagnosis other than schizophrenia
- At significant risk of suicide, and the potential for violent behavior (likely to harm
themselves or others) based on history
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Descriptive Information | ||||
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Brief Title ICMJE | Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients | |||
Official Title ICMJE | A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients | |||
Brief Summary | The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks. | |||
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 | |||
Actual Enrollment ICMJE | 83 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 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 | Argentina, Canada, Chile, Czech Republic, Estonia, Finland, Germany, Hungary, Latvia, Lithuania, Peru, Slovakia, South Africa, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00396214 | |||
Other Study ID Numbers ICMJE | S154.3.021 2006-004973-83 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Loretta Stallings, Solvay Pharmaceuticals | |||
Study Sponsor ICMJE | Solvay Pharmaceuticals | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Solvay Pharmaceuticals | |||
Verification Date | May 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |