Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy

简要总结

主要结局

次要结局

• Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores(Baseline and weekly from Weeks 1-18)
• Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test(Baseline and Weeks 12 and 18)
• Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores(Baseline and Weeks 4, 8, 12, and 18)
• Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores(Screening and Weeks 1, 8, 12, and 18)
• Change from baseline to endpoint in PANSS subscale scores(Baseline and weekly from Weeks 1-18)
• Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores(Baseline and Weeks 8, 12, and 18)
• Change from baseline in laboratory tests(Screening and weekly from Weeks 1-18)
• Proportion of responders, based on change from baseline to endpoint in PANSS total score(Until Final Visit (within 18 weeks))
• Time to discontinuation(Up to 18 weeks)
• Change from baseline in Caregiver Activity Survey (CAS)(Screening and Weeks 1, 8, 12, and 18)
• Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores(Baseline and Week 8, 12, and 18)
• Adverse events(Weekly from Weeks 1-18)
• Change from baseline in electrocardiogram(Screening and Weeks 1, 8, 12, and 18)
• Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale(Baseline and Weeks 1, 8, 12, and 18)
• Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores(Baseline and weekly from Weeks 1-18)
• Change from baseline to endpoint in Patient Preference Scale (PPS) scores(Screening and Weeks 1, 8, 12, and 18)