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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Pfizer Investigational Site
Budapest, Hungary
Pfizer Investigational Site
Debrecen, Hungary
Pfizer Investigational Site
Esztergom, Hungary
Pfizer Investigational Site
Kecskemét, Hungary
Pfizer Investigational Site
Kistarcsa, Hungary
Pfizer Investigational Site
Pécs, Hungary
Pfizer Investigational Site
Székesfehérvár, Hungary
Pfizer Investigational Site
Tatabánya, Hungary
Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
Safety- Incidence and severity of the side effects
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
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