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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00563706 |
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Date of registration:
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21/11/2007 |
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Primary sponsor: |
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Public title:
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Study Evaluating Vabicaserin in Subjects With Schizophrenia
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Scientific title:
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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 |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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199 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00563706 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: risperidone
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Drug: vabicaserin
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Other: placebo
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Primary Outcome(s)
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The primary efficacy endpoint is the change in the PANSS total score from baseline to the end of the double-blind treatment period (day 28).
[Time Frame: 4 weeks]
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Secondary ID(s)
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3153A1-2203
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B1911032
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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