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

This study has been terminated.
(See Detailed Description for Termination Reason)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159757
First received: September 8, 2005
Last updated: August 1, 2007
Last verified: August 2007
  Purpose

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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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


Condition Intervention Phase
Schizophrenia
Drug: ziprazidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 150
Study Start Date: November 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159757

Locations
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, Hungary
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00159757     History of Changes
Other Study ID Numbers: A1281122
Study First Received: September 8, 2005
Last Updated: August 1, 2007
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014