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

Phase 4

Terminated

• Conditions: Schizophrenia

• Registration Number: NCT00159757
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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

Detailed 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.

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
Safety- Incidence and severity of the side effects

Secondary Outcome Measures

Name	Time	Method
To evaluate the influence on the body weight change.
To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)
To assess the subject's antidepressive efficacy by Calgary and Hamilton depression scales
To assess the subject's view on the treatment with ziprasidone

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇭🇺 Tatabanya, Hungary