Study Evaluating Vabicaserin in Subjects With Schizophrenia
NCT00563706
ABOUT THIS STUDY
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- Generally healthy, men and women, aged 18 to 65.
- Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
- Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.
- Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR
criteria).
- Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria),
including alcohol (except for nicotine), within 3 months before baseline (day -1).
- Subjects taking high or chronic doses of benzodiazepine at the screening evaluation
who, in the investigator's judgment, would be likely to have severe withdrawal
symptoms upon discontinuation.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Vabicaserin in Subjects With Schizophrenia | |||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia | |||
Brief Summary | The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
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 | Completed | |||
Actual Enrollment ICMJE | 199 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | June 2008 | |||
Actual Primary Completion Date | June 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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00563706 | |||
Other Study ID Numbers ICMJE | 3153A1-2203 B1911032 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |