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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Ziprasidone

Criteria

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.