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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
ziprazidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 8, 2005
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00159757
Brief Title
12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description for Termination Reason
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Budapest
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Esztergom
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Kecskemet
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Kistarcsa
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Pecs
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szekesfehervar
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Tatabanya
Country
Hungary

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281122&StudyName=12+Week+Open%2C+Non%2DComparative+Switch+Study+Of+Oral+Ziprazidone+In+Previously+Treated+Schizophrenic+Patients
Description
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12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

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