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Am J Psychiatry 1994; 151:825-835
Copyright © 1994 by American Psychiatric Association
Risperidone in the treatment of schizophrenia
SR Marder and RC Meibach
West Los Angeles VA Medical Center, CA 90073.
OBJECTIVE: The purpose of this study was to investigate the safety and
efficacy of risperidone in the treatment of schizophrenic patients and
determine its optimal dose. METHOD: This double-blind study included 388
schizophrenic patients drawn from 20 sites in the United States. Patients
were randomly assigned to 8 weeks' treatment with placebo, one of four
doses of risperidone (2, 6, 10, or 16 mg), or 20 mg of haloperidol daily.
RESULTS: Clinical improvement (20% reduction in total scores on the
Positive and Negative Syndrome Scale for Schizophrenia) at the study end
point was shown by 35% of the patients receiving 2 mg of risperidone, 57%
receiving 6 mg, 40% receiving 10 mg, and 51% receiving 16 mg; and by 30%
receiving haloperidol and 22% receiving placebo. Statistically significant
differences in clinical improvement were found between 6 and 16 mg of
risperidone versus placebo and versus haloperidol. Positive symptom scores
were significantly lower after 6, 10, and 16 mg of risperidone and 20 mg of
haloperidol than placebo; negative symptom scores, however, were reduced
significantly, compared with placebo, only after 6 and 16 mg of
risperidone. The incidence of extra-pyramidal side effects (measured by the
Extrapyramidal Symptom Rating Scale) was significantly higher in patients
treated with 16 mg of risperidone or 20 mg of haloperidol than placebo. The
results indicate that the optimal daily dose of risperidone for most
schizophrenic patients in this study was 6 mg; this dose was as effective
as 16 mg, and the incidence of extrapyramidal symptoms in patients
receiving 6 mg of risperidone was no higher than that in patients receiving
placebo. CONCLUSIONS: Risperidone is a safe antipsychotic that is effective
against both the positive and negative symptoms of schizophrenia.
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