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A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00650429
Collaborator
(none)
28
Enrollment
4
Locations
1
Arm
19
Duration (Months)
7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
Study Start Date :
Oct 1, 2003
Actual Study Completion Date :
May 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: Ziprasidone
IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
Other Names:
  • Geodon, Zeldox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    Secondary Outcome Measures

    1. Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    2. Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score [Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    3. Simpson-Angus Scale (SAS) [Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)]

    4. Barnes Akathisia Scale (BAS) [Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)]

    5. Laboratory tests [Screening and Week 6]

    6. Electrocardiogram [Screening and Week 6]

    7. Adverse events [Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    8. Abnormal Involuntary Movement Scale (AIMS) [Day 1 (IM), Day 4 (Switch), and Week 6 (PO)]

    9. Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    10. Change from baseline to endpoint in Covi Anxiety Scale score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    11. Change from baseline to endpoint in Positive PANSS subscale score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    12. Change from baseline to endpoint in Negative PANSS subscale score [Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)]

    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 or schizoaffective disorder.

    • Inpatients with acute exacerbation of psychotic symptoms.

    • Patients with a minimum score of 40 on the BPRS scale (1-7).

    Exclusion Criteria:

    • Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.

    • Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.

    • Patients currently receiving clozapine.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Monterrey Nuevo LEON Mexico 64800
    2 Pfizer Investigational Site DF Mexico 14420
    3 Pfizer Investigational Site Mexico City Mexico 14050
    4 Pfizer Investigational Site Mexico D F Mexico 14269

    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:
    NCT00650429
    Other Study ID Numbers:
    • A1281056
    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