G. Bondolfi et al., RISPERIDONE VERSUS CLOZAPINE IN TREATMENT-RESISTANT CHRONIC-SCHIZOPHRENIA - A RANDOMIZED DOUBLE-BLIND-STUDY, The American journal of psychiatry, 155(4), 1998, pp. 499-504
Objective: The purpose of this study was to compare the short-term eff
icacy and safety of risperidone and clozapine in treatment-resistant c
hronic schizophrenic patients. Method: In a controlled double-blind, m
ulticenter study, 86 inpatients with chronic schizophrenia (DSM-III-R)
, who were resistant to or intolerant of conventional neuroleptics, we
re randomly assigned to receive risperidone or clozapine for 8 weeks a
fter a 7-day washout period. After a I-week dose-titration phase, dose
s were fixed at 6 mg/day of risperidone and 300 mg/day of clozapine fo
r 1 week and then adjusted according to each patient's response. The f
inal mean noses were 6.4 mg/day of risperidone and 291.2 mg/day Of clo
zapine. Treatment efficacy and safety were evaluated with several well
-known rating scales. Results: Both risperidone and clozapine signific
antly reduced the severity of psychotic symptoms (scores on the Positi
ve and Negative Syndrome Scale and the Clinical Global Impression scal
e) from baseline, with no significant between-group differences. At en
dpoint, 67% of the risperidone group and 65% of the clozapine group we
re clinically improved (reduction of 20% or more in total Positive and
Negative Syndrome Scale score). Risperidone appeared to have a faster
onset of action. In both groups extrapyramidal symptoms and other adv
erse events were few, and their severity was generally mild. Neither g
roup showed evidence of a relation between drug plasma concentrations
and clinical effectiveness. Conclusions: Risperidone was well tolerate
d and as effective as medium doses of clozapine in patients with chron
ic schizophrenia who had been resistant to or intolerant of convention
al neuroleptics.