Observational postmarketing study on efficacy and safety of novel generic risperidone risset(r) in patients with acute or chronic schizophrenic or other related psychosis.

Objective. The aim of this study was to establish the effectiveness and safety of risperidone (Risset(R) - PLIVA) in patients with acute or chronic schizophrenic or other related psychosis. Study was designed as postmarketing, 4-week, open-label, flexible-dose observational study. Subjects and Methods. 30 patients, both genders, aged 18-70 years, with diagnosed various types of schizophrenic psychosis were enrolled in the study as outpatient and inpatient setting. The patients had to have a total score >/=40 on Positive and Negative scale - two parts of the Positive and Negative Syndrome Scale (PANSS), and to be able to discontinue current antipsychotic and antiparkinsonian medications. The primary efficacy parameter was the percent of score difference between baseline and week 4 of therapy on two above-mentioned PANSS subscales. The difference was considered as significant improvement if decrease from the baseline was 20% or more. The safety of risperidone was evaluated on the basis of reported adverse events. Results. All 30 enrolled patients completed the study. After the 4 weeks of treatment, 23/30 patients (76.67%) had clinically significant improvement of 20% or more decreased total PANSS score (Positive and Negative subscale). In 4/30 patients (13.33%) clinical improvement was also reported with <20% decreased total PANSS score. No serious adverse event was observed. Conclusions. Overall, collected data indicate that in this specific population (70% patients were resistant to previous anti-psychotic therapy), Risset(R) has shown very good effectiveness and safety.