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A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00645229
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
5.9
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Study Start Date :
Sep 1, 2004
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: Ziprasidone
Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
Other Names:
  • Geodon, Zeldox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 [Week 24]

    2. Change from baseline in PANSS (Depression-C) score at Week 24 [Week 24]

    3. Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 [Week 24]

    4. Change from baseline in CGI-S total score at Week 24 [Week 24]

    Secondary Outcome Measures

    1. Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6]

    2. Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 [Week 24]

    3. Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6]

    4. Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 [Week 24]

    5. Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6]

    6. Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6]

    7. Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6]

    8. Electrocardiogram [Screening and Month 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients not currently being treated with antipsychotic medication and neuroleptic naive patients

    • Diagnosis of schizophrenia or schizoaffective disorder

    • Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

    Exclusion Criteria:

    • Patients at immediate risk of committing harm to self or others

    • Treatment with clozapine within 3 months prior to baseline

    • History of neuroleptic treatment

    • Current antipsychotic treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Lisboa Portugal 1600-219

    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:
    NCT00645229
    Other Study ID Numbers:
    • A1281055
    First Posted:
    Mar 27, 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