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

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

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 Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Ziprasidone; Drug: Risperidone

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Pfizer Investigational Site
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48010
      • Pfizer Investigational Site
    • Getxo, Vizcaya, Spain, 48990
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	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: Geodon, Zeldox
Active Comparator: Arm B	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone; Ziprasidone
• Other Study ID Numbers: A1281065