Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
NCT00768612
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- Male and female subjects between >=20 and =<65 years of age
- Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
- Total PANSS score >=70 and =< 120
- Subjects who are hospitalized against their will
- Current Axis I primary psychiatric diagnosis other than schizophrenia
- A score of 3 on CDSS question 8 which pertains to suicide
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia | |||
Official Title ICMJE | A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia | |||
Brief Summary | This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double 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Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Estimated Study Completion Date ICMJE | July 2009 | |||
Estimated Primary Completion Date | July 2009 (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 | 20 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 | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00768612 | |||
Other Study ID Numbers ICMJE | 3153B1-2208 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |