A Randomized Controlled Trial of Risperidone in the Treatment of Aggression in Hospitalized Adolescents With Subaverage Cognitive Abilities

Background: Risperidone is an atypicalantipsychotic drug that blocks dopamine as well as serotoninreceptor systems. The present study was designed to examine theefficacy and safety of risperidone in a 6-week double-blind,randomized, parallel-group design in the treatment of aggressionin adolescents with a primary diagnosis of DSM-IV disruptivebehavior disorders and with subaverage intelligence.

Method: We randomly assigned 38adolescents (33 boys; 10 subjects with slightly subaverage IQ, 14with borderline IQ, and 14 with mild mental retardation), whowere hospitalized for treatment of psychiatric disordersassociated with severe aggression, to receive risperidone orplacebo. The main efficacy measures were the Clinical GlobalImpressions-Severity of Illness scale (CGI-S), the modified OvertAggression Scale (OAS-M), and the Aberrant Behavior Checklist(ABC). Side effects were measured using the ExtrapyramidalSymptom Rating Scale (ESRS).

Results: The mean daily dose of risperidone atthe end of treatment was 2.9 mg (range, 1.5-4 mg). Risperidone,compared with placebo, was associated with significantimprovements on the CGI-S (p < .001) and the at-school ABCoverall and hyperactivity scales (p < .05). During a 2-weekwashout following the 6-week trial, a statistically significantworsening was found in the risperidone group on the CGI-S scale,the OAS-M, and the ABC. Extrapyramidal symptoms were absent orvery mild during risperidone treatment. Transient tiredness waspresent in 11 (58%) of 19 drug-treated subjects. Other untowardeffects included sialorrhea, nausea, and slight weight gain (mean= 3.5% of body weight in the risperidone group). No clinicallyrelevant changes were found in laboratory parameters,electrocardiogram, heart rate, or blood pressure.

Conclusion: These results suggest thatrisperidone may be effective for severe aggression in adolescentswith disruptive behavior disorders and subaverage intelligence,and these results are consistent with reports suggesting itseffectiveness for treating severe aggression in adolescents ingeneral.