Hj. Moller et al., RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA - RESULTS OF A STUDY OFPATIENTS FROM GERMANY, AUSTRIA, AND SWITZERLAND, European archives of psychiatry and clinical neuroscience, 247(6), 1997, pp. 291-296
Results of a subanalysis of data from the multinational risperidone tr
ial (RIS-INT-2) are reported. Patients with chronic schizophrenia were
treated with risperidone at 1 mg/day (n = 25), 4 mg/day (n = 27), 8 m
g/day (n = 29), 12 mg/day (n = 31), or 16 mg/day (n = 29), or 10 mg/da
y of haloperidol for 8 weeks. According to the Positive and Negative S
yndrome Scale (PANSS) total and subscale scores, improvements were not
ed in each treatment group from baseline to treatment endpoint. On eac
h scale the magnitude of improvement was greater in the risperidone pa
tients than in the haloperidol patients. The onset of action of risper
idone was faster than haloperidol. By treatment week 2, over half of t
he patients receiving 4 mg/day of risperidone were clinically improved
greater than or equal to (greater than or equal to 20% reduction in t
otal PANSS scores). This rate of improvement was not seen until week 6
in the haloperidol patients. Severity of extrapyramidal symptoms (sco
res on the Extrapyramidal Symptom Scale) was significantly lower in pa
tients receiving 1 or 4 mg/day of risperidone than in patients receivi
ng higher risperidone doses and in haloperidol patients. The optimal d
ose of risperidone, in terms of both efficacy and safety, was 4 mg/day
. These results confirm the findings of the controlled trials of rispe
ridone conducted in North America and the multinational trial.