The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
242
Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6
Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Guangzhou, China
Pfizer Investigational Site
Nanjing, China
Pfizer Investigational Site
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Week 6
Adverse events, laboratory test changes, movement disorder scale scores
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS negative subscale score
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS general psychopathology subscale score
Time frame: Weeks 1, 2, 4, and 6
PANSS responder rate
Time frame: Weeks 1, 2, 4 and 6
Clinical Global Impression-Severity (CGI-S) score
Time frame: Baseline and Weeks 1, 2, 4, and 6
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS positive subscale score
Time frame: Weeks 1, 2, 4, and 6
Clinical Global Impression-Improement (CGI-I) score
Time frame: Weeks 1, 2, 4, and 6
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Shanghai, China