Clinical trial NCT00159757: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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

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

Primary outcomes:
measure: Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
measure: Safety- Incidence and severity of the side effects
Secondary outcomes:
measure: To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)
measure: To evaluate the influence on the body weight change.
measure: To assess the subject's view on the treatment with ziprasidone
measure: To assess the subject's antidepressive efficacy by Calgary and Hamilton depression scales
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Esztergom
country: Hungary
facility: Pfizer Investigational Site
city: Kecskemet
country: Hungary
facility: Pfizer Investigational Site
city: Kistarcsa
country: Hungary
facility: Pfizer Investigational Site
city: Pecs
country: Hungary
facility: Pfizer Investigational Site
city: Szekesfehervar
country: Hungary
facility: Pfizer Investigational Site
city: Tatabanya
country: Hungary
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: