12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

• Status: Terminated
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.

• 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:

• confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files

• subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria:

• patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)

• in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms