LONG-TERM TREATMENT OF CHRONIC-SCHIZOPHRENIA WITH RISPERIDONE - AN OPEN-LABEL, MULTICENTER STUDY OF 386 PATIENTS

An open-label, multicentre study was conducted to assess the long-term efficacy and safety of risperidone in patients,vith chronic schizophr enia. Three hundred and eighty-six patients at 70 centres in 11 countr ies received risperidone (2-16 mg/day) for up to 57 weeks; 247 patient s were treated for at least 1 year. All but 48 patients had been treat ed,vith antipsychotic agents before entering the trial. The mean (+/- SD) daily risperidone dose at endpoint was 8.6 +/- 4.4 mg. The mean to tal Positive and Negative Syndrome Scale (PANSS) scores were reduced s ignificantly from 76.7 at baseline to 67.4 at endpoint (p < 0.001). Ev en though no patients had acutely exacerbated symptoms at the start of the trial, mean scores on each of the PANSS positive, negative, and g eneral psychopathology subscales were significantly reduced during the first month of open treatment, and these mean scores continued to imp rove over the course of the trial. At endpoint, 64% of patients were r ated as improved on the Clinical Global Impression change scale. Extra pyramidal symptoms (scores on the Extrapyramidal Symptom Rating Scale) tended to decrease in severity or remained unchanged over the course of risperidone treatment; 27.7% of patients required antiparkinsonian medication during the study. The results demonstrate that risperidone' s efficacy against the positive and negative symptoms of chronic schiz ophrenia can be maintained in long-term treatment with a low incidence of adverse experiences; moreover, the drug reduces preexisting extrap yramidal symptoms over time. Int Clin Psychopharmacol 13:99-106 (C) 19 98 Lippincott-Raven Publishers.