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

Viatris

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Drug: Ziprasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00650429

A1281056

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.