Archive 1995–2023
1998, volume 14, issue 4
Article
Risperidon (Rispolept®) w leczeniu schizofrenii – wyniki badania wieloośrodkowego w Polsce
Farmakoterapia w Psychiatrii i Neurologii, 1998, 4, 13-32
Summary
The results of a long term (7 months) clinical trial evaluating efficacy and safety of risperidone in treatment of schizophrenia are presented (DSM-3-R). The study was conducted in 14 clinical centers in Poland; 193 patients aged 15-65 years were enrolled. Efficacy parameters were estimated in PANSS (total and subscales) and CGI. Safety was assessed by analysis of vital signs, clinical laboratory tests, ECG, adverse events and extrapyramidal symptoms by means of the ESRS. The result s of the study confirmed high efficacy of risperidone in the treatment of positive and negative symptoms of schizophrenia. Low incidences of adverse events, particularly extrapyramidal symptoms, prove good safety and tolerability profile of risperidone.