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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00645515
Collaborator
(none)
240
3
2
6
80
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
Study Start Date :
Jun 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change from baseline in cognitive function assessment at Weeks 4 and 24 [Day 1 and Weeks 4 and 24]

    2. 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]

    3. Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24 [Day 1 and Weeks 1, 4, 12, 16, and 24]

    4. Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24 [Day 1 and Weeks 1, 4, 12, 16, and 24]

    5. 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]

    6. Laboratory tests and electrocardiogram at Week 24 [Screening and Week 24]

    7. 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]

    8. 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]

    9. 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]

    10. 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]

    11. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Bilbao Vizcaya Spain 48010
    2 Pfizer Investigational Site Getxo Vizcaya Spain 48990
    3 Pfizer Investigational Site Madrid Spain 28007

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00645515
    Other Study ID Numbers:
    • A1281065
    First Posted:
    Mar 27, 2008
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2021