A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00644800
Collaborator
(none)
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Study Details

Study Description

Brief Summary

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis
Study Start Date :
Jul 1, 2003
Actual Study Completion Date :
May 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: Ziprasidone
Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
Other Names:
  • Geodon, Zeldox
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores [Days 1-3 (end of intramuscular dosing)]

    Secondary Outcome Measures

    1. Electrocardiogram at Visits 1 and 5 [Visits 1 (Screening) and 5 (Day 7)]

    2. Adverse events at Visits 2, 3, 4, and 5 [Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)]

    3. Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5 [Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)]

    4. Laboratory tests at Visits 1 and 5 [Visits 1 (Screening) and 5 (Day 7)]

    5. Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5 [Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)]

    6. Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5 [Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)]

    7. Blood pressure and pulse at Visits 1, 2, and 5 [Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)]

    8. Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5 [Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hospitalized patients with psychosis

    • Eligible for intramuscular treatment

    • Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

    Exclusion Criteria:
    • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks

    • Resistance to conventional antipsychotic agents

    • A history of epilepsy

    • A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Salvador Bahia Brazil 41180-000
    2 Pfizer Investigational Site Fortaleza Ceara Brazil 60175-270
    3 Pfizer Investigational Site Belo Horizonte MG Brazil 30150-270
    4 Pfizer Investigational Site Curitiba PR Brazil
    5 Pfizer Investigational Site Rio de Janeiro RJ Brazil
    6 Pfizer Investigational Site Sao Goncalo RJ Brazil
    7 Pfizer Investigational Site Jardim Santa Monica SN Salvador - BA Brazil 40340-720
    8 Pfizer Investigational Site Sao Paulo SP Brazil

    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:
    NCT00644800
    Other Study ID Numbers:
    • A1281074
    First Posted:
    Mar 27, 2008
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021

    Study Results

    No Results Posted as of Feb 21, 2021