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

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone; Drug: Ziprasidone

• Registration Number: NCT00645515
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2003-12
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Risperidone	-
Arm A	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Laboratory tests and electrocardiogram at Week 24	Screening and Week 24
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
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 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
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Madrid, Spain