A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
- Registration Number
- NCT00645372
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria
- Hospitalized patients with schizophrenia
- Miminum PANSS score of 60 when randomized
Exclusion Criteria
- Planned, regular use of antipsyhotics within 1 week of randomization
- Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Ziprasidone - A Risperidone -
- Primary Outcome Measures
Name Time Method Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score Week 6
- Secondary Outcome Measures
Name Time Method Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score Weeks 1, 2, 4, and 6 Adverse events, laboratory test changes, movement disorder scale scores Weeks 1, 2, 4, and 6 Clinical Global Impression-Severity (CGI-S) score Baseline and Weeks 1, 2, 4, and 6 Clinical Global Impression-Improement (CGI-I) score Weeks 1, 2, 4, and 6 Change from baseline in PANSS negative subscale score Weeks 1, 2, 4, and 6 Change from baseline in PANSS general psychopathology subscale score Weeks 1, 2, 4, and 6 Change from baseline in PANSS positive subscale score Weeks 1, 2, 4, and 6 PANSS responder rate Weeks 1, 2, 4 and 6
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Shanghai, China
Pfizer Investigational Site🇨🇳Shanghai, China