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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country75 target enrollmentAugust 2003

ConditionsPyschotic Disorders

InterventionsZiprasidone

DrugsZiprasidone

Overview

Phase: Phase 4
Intervention: Ziprasidone
Conditions: Pyschotic Disorders
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 75
Locations: 1
Primary Endpoint: Change from baseline in Clinical Global Impression-Severity (CGI-S) score
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

August 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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.)