Schizophrenia
Conditions
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that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy.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.
Interventions
DRUGziprazidone
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score | — |
| Safety- Incidence and severity of the side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hungary
Outcome results
None listed