A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Ziprasidone
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia CGI-S score of 4 or less at baseline Exclusion Criteria: Concurrent antipsychotic treatment Treatment with antidepressants or mood stabilizers within 2 weeks of randomization Acute exacerbation of schizophrenia within 3 months of baseline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: Ziprasidone<br>* 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.<br>* Other names: Geodon, Zeldox;|
| Active Comparator: Arm B<br> | Drug: Risperidone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |