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

Schizophrenia Clinical Trial

Official title:

12 Week Open Label, Multicenter, Non-Comparative Switch Study Evaluating Efficacy, Tolerability And Safety Of Oral Ziprasidone In Treatment Of Patients Suffering From Schizophrenia Who Have Already Been Treated With An Other Antipsychotic.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159757
• Other study ID #: A1281122
• Status: Terminated
• Phase: Phase 4
• Start date: November 2003
• Est. completion date: February 2005

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ziprazidone

Locations

Country	Name	City	State
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Esztergom
Hungary	Pfizer Investigational Site	Kecskemet
Hungary	Pfizer Investigational Site	Kistarcsa
Hungary	Pfizer Investigational Site	Pecs
Hungary	Pfizer Investigational Site	Szekesfehervar
Hungary	Pfizer Investigational Site	Tatabanya

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
Primary	Safety- Incidence and severity of the side effects
Secondary	To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)
Secondary	To evaluate the influence on the body weight change.
Secondary	To assess the subject's view on the treatment with ziprasidone
Secondary	To assess the subject's antidepressive efficacy by Calgary and Hamilton depression scales

External Links

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