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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159757
Recruitment Status : Terminated (See Detailed Description for Termination Reason)
First Posted : September 12, 2005
Last Update Posted : August 2, 2007
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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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ziprazidone Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
  2. Safety- Incidence and severity of the side effects

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159757

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
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00159757     History of Changes
Other Study ID Numbers: A1281122
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents