Hj. Moller et al., LONG-TERM TREATMENT OF CHRONIC-SCHIZOPHRENIA WITH RISPERIDONE - AN OPEN-LABEL, MULTICENTER STUDY OF 386 PATIENTS, International clinical psychopharmacology, 13(3), 1998, pp. 99-106
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.