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A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00649064
Collaborator
(none)
46
Enrollment
3
Locations
1
Arm
9
Duration (Months)
15.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder
Study Start Date :
Dec 1, 2003
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ziprasidone

Drug: Ziprasidone
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
Other Names:
  • Geodon, Zeldox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score [Week 6]

    Secondary Outcome Measures

    1. Adverse events [Weeks 1, 2, and 6]

    2. Change from baseline in weight [Baseline and Week 6]

    3. Change from baseline in prolactin and lipid levels [Baseline and Week 6]

    4. Change from baseline in electrocardiogram [Baseline and Week 6]

    5. Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores [Baseline and Weeks 1, 2, and 6]

    6. Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores [Baseline and Weeks 1, 2, and 6]

    7. Clinical Global Impressions-Improvement (CGI-I) scale scores [Baseline (using historical data) and Weeks 1, 2, and 6]

    8. Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS) [Baseline and Week 6]

    9. Change from baseline in vital signs [Baseline and Weeks 1, 2, and 6]

    10. Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores [Baseline and Week 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of schizophrenia or schizoaffective disorder

    • Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode

    • Partial improvement in symptoms that justified a switch to ziprasidone

    Exclusion Criteria:

    • Diagnosis of major depression or occurrence of moderate depressive symptoms

    • Resistance to conventional antipsychotic drugs

    • Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Changhua Taiwan
    2 Pfizer Investigational Site Tainan Taiwan
    3 Pfizer Investigational Site Taipei Taiwan

    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:
    NCT00649064
    Other Study ID Numbers:
    • A1281120
    First Posted:
    Apr 1, 2008
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Schizophrenia
    Psychotic Disorders
    Ziprasidone

    Study Results

    No Results Posted as of Feb 21, 2021