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

Phase 3TerminatedNCT00645515

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Schizophrenia

Interventions

ZiprasidoneDRUG

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.

RisperidoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

Bilbao, Vizcaya, Spain

Pfizer Investigational Site

Getxo, Vizcaya, Spain

Pfizer Investigational Site

Madrid, Spain

Outcomes

Primary Outcomes

Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Secondary Outcomes

Change from baseline in cognitive function assessment at Weeks 4 and 24

Time frame: Day 1 and Weeks 4 and 24

Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24

Time frame: Day 1 and Weeks 4, 10, 12, 16, and 24

Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24

Time frame: Day 1 and Weeks 1, 4, 12, 16, and 24

Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24

Time frame: 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

Time frame: Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24

Laboratory tests and electrocardiogram at Week 24

Time frame: Screening and Week 24

Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Time frame: 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

Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Data from ClinicalTrials.gov

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