Status:
COMPLETED
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pyschotic Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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).
Eligibility Criteria
Inclusion
- Psychotic disorder
- Completion of previous study of intramuscular ziprasidone
- Ability to continue with oral ziprasidone
Exclusion
- 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.)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00645320
Start Date
August 1 2003
End Date
August 1 2004
Last Update
February 21 2021
Active Locations (8)
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1
Pfizer Investigational Site
RIO de Janeiro RJ, Brazil, Brazil, 22640-100
2
Pfizer Investigational Site
Fortaleza, Ceará, Brazil, 60175-270
3
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil, 41180-000
4
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-270