A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone

The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • RIO DE Janeiro RJ, Brazil, 22640-100
        • Pfizer Investigational Site
    • Bahia
      • Salvador, Bahia, Brazil, 41180-000
        • Pfizer Investigational Site
    • Ceara
      • Fortaleza, Ceara, Brazil, 60175-270
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brazil, 30150-270
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brazil
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil
        • Pfizer Investigational Site
    • Salvador - BA
      • Jardim Santa Monica SN, Salvador - BA, Brazil, 40340-720
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Psychotic disorder
  • Completion of previous study of intramuscular ziprasidone
  • Ability to continue with oral ziprasidone

Exclusion Criteria:

  • Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment.
  • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks.
  • Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Ziprasidone
Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
Other Names:
  • Geodon, Zeldox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Clinical Global Impression-Severity (CGI-S) score
Time Frame: Until Final Visit (within 3 months)
Until Final Visit (within 3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Baseline and Months 1, 2, and 3
Baseline and Months 1, 2, and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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