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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00645515
• Other study ID #: A1281065
• Status: Terminated
• Phase: Phase 3
• Start date: June 2003
• Est. completion date: December 2003

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Pfizer Investigational Site	Bilbao	Vizcaya
Spain	Pfizer Investigational Site	Getxo	Vizcaya
Spain	Pfizer Investigational Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in cognitive function assessment at Weeks 4 and 24		Day 1 and Weeks 4 and 24
Secondary	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
Secondary	Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24		Day 1 and Weeks 1, 4, 12, 16, and 24
Secondary	Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24		Day 1 and Weeks 1, 4, 12, 16, and 24
Secondary	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
Secondary	Laboratory tests and electrocardiogram at Week 24		Screening and Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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