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

Viatris

Status and phase

Terminated

Phase 4

Conditions

Schizophrenia

Treatments

Drug: ziprazidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159757

A1281122

Details and patient eligibility

About

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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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.

Full description

Study was terminated due to difficulty in enrolling the targeted number of patients on March 1, 2005, last subject last visit date was Feb.16, 2005. There were no safety concerns involved in the decision to terminate the trial.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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