A Randomized Controlled Trial of Risperidone in the Treatment of Aggression in Hospitalized Adolescents With Subaverage Cognitive Abilities
J Clin Psychiatry 2001;62(4):239-248
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Risperidone is an atypical
antipsychotic drug that blocks dopamine as well as serotonin
receptor systems. The present study was designed to examine the
efficacy and safety of risperidone in a 6-week double-blind,
randomized, parallel-group design in the treatment of aggression
in adolescents with a primary diagnosis of DSM-IV disruptive
behavior disorders and with subaverage intelligence.
Method: We randomly assigned 38
adolescents (33 boys; 10 subjects with slightly subaverage IQ, 14
with borderline IQ, and 14 with mild mental retardation), who
were hospitalized for treatment of psychiatric disorders
associated with severe aggression, to receive risperidone or
placebo. The main efficacy measures were the Clinical Global
Impressions-Severity of Illness scale (CGI-S), the modified Overt
Aggression Scale (OAS-M), and the Aberrant Behavior Checklist
(ABC). Side effects were measured using the Extrapyramidal
Symptom Rating Scale (ESRS).
Results: The mean daily dose of risperidone at
the end of treatment was 2.9 mg (range, 1.5-4 mg). Risperidone,
compared with placebo, was associated with significant
improvements on the CGI-S (p < .001) and the at-school ABC
overall and hyperactivity scales (p < .05). During a 2-week
washout following the 6-week trial, a statistically significant
worsening was found in the risperidone group on the CGI-S scale,
the OAS-M, and the ABC. Extrapyramidal symptoms were absent or
very mild during risperidone treatment. Transient tiredness was
present in 11 (58%) of 19 drug-treated subjects. Other untoward
effects included sialorrhea, nausea, and slight weight gain (mean
= 3.5% of body weight in the risperidone group). No clinically
relevant changes were found in laboratory parameters,
electrocardiogram, heart rate, or blood pressure.
Conclusion: These results suggest that
risperidone may be effective for severe aggression in adolescents
with disruptive behavior disorders and subaverage intelligence,
and these results are consistent with reports suggesting its
effectiveness for treating severe aggression in adolescents in