A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A
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Drug: Ziprasidone
Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
Other Names:
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Active Comparator: Arm B
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Drug: Risperidone
Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
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Outcome Measures
Primary Outcome Measures
- Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24]
Secondary Outcome Measures
- Change from baseline in cognitive function assessment at Weeks 4 and 24 [Day 1 and Weeks 4 and 24]
- Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24 [Day 1 and Weeks 4, 10, 12, 16, and 24]
- Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24 [Day 1 and Weeks 1, 4, 12, 16, and 24]
- Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24 [Day 1 and Weeks 1, 4, 12, 16, and 24]
- Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24 [Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24]
- Laboratory tests and electrocardiogram at Week 24 [Screening and Week 24]
- Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24]
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24]
- Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24]
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24 [Day 1 and Weeks 4, 10, 12, 16, and 24]
- Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24 [Day 1 and Weeks 4, 10, 12, 16, and 24]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of schizophrenia
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CGI-S score of 4 or less at baseline
Exclusion Criteria:
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Concurrent antipsychotic treatment
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Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
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Acute exacerbation of schizophrenia within 3 months of baseline
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pfizer Investigational Site | Bilbao | Vizcaya | Spain | 48010 |
2 | Pfizer Investigational Site | Getxo | Vizcaya | Spain | 48990 |
3 | Pfizer Investigational Site | Madrid | Spain | 28007 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1281065