To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
NCT00141479
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- Diagnosis of Schizophrenia or Schizoaffective disorder
- 18-55 years
- Subjects who are acutely psychotic
- Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
- Subjects at significant risk of suicide
- Subjects with a seizure disorder
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Descriptive Information | ||||
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Brief Title ICMJE | To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox | |||
Official Title ICMJE | A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder | |||
Brief Summary | The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Bifeprunox | |||
Study Arms ICMJE | Not Provided | |||
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 | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | November 2006 | |||
Actual Primary Completion Date | November 2006 (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 55 Years (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 | NCT00141479 | |||
Other Study ID Numbers ICMJE | S154.2.013 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Solvay Pharmaceuticals | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Solvay Pharmaceuticals | |||
Verification Date | May 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |