GENIOUS, a non-interventional under standard practice study examined and evaluated the efficacy and safety of ziprasidone in 963 schizophrenia patients from 43 Greek centers.
Ziprasidone was administered orally (p.o.) and/or intramuscularly (i.m.). The oral doses ranged from 40 to 320 mg per day and in the majority of patients were between 80 and 160 mg. The efficacy of ziprasidone was measured using selected parts of the Positive and Negative Syndrome Scale (PANSS), the Calgary Depression Scale (CDSS) and the Clinical Global Impression-Improvement Scale (CGI-I). The evaluation of safety was carried out by measuring the mean change in weight from baseline until end of treatment and by recording all other adverse events.
A mean improvement of 5.8 points was observed in the positive subscale of PANSS (95% CI = -6.10 to -5.43). In the negative subscale, 53.3% of the patients showed improvement in blunted affect, 58.8% in poor rapport, and 59.4% in difficulty in abstract thinking. A significant improvement was also observed in CDSS (-1.4 points, 95% CI = -1.5 to -1.2) with 40.3% of the patients showing remission of depression. Overall, a responder rate of 85.3% was observed for the CGI scale. Discontinuation of treatment due to adverse events was recorded in only 5.7% of the patients. However, only 4.2% were attributed to ziprasidone. No weight gain was observed.
The administration of ziprasidone constitutes a safe and effective therapeutic choice for the treatment of the positive and negative symptoms in Greek patients with schizophrenia.