A randomized controlled trial of risperidone in the treatment of aggression in hospitalized adolescents with subaverage cognitive abilities

Background: Risperidone is an atypical antipsychotic drug that blocks dopam ine as well as serotonin receptor systems. The present study was designed t o examine the efficacy and safety of risperidone in a 6-week double-blind, randomized, parallel-group design in the treatment of aggression in adolesc ents with a primary diagnosis of DSM-IV disruptive behavior disorders and w ith subaverage intelligence. Method: We randomly assigned 38 adolescents (33 boys; 10 subjects with slig htly subaverage IQ, 14 with borderline IQ, and 14 with mild mental retardat ion), who were hospitalized for treatment of psychiatric disorders associat ed with severe aggression, to receive risperidone or placebo. The main effi cacy measures were the Clinical Global Impressions-Severity of Illness scal e (CGI-S), the modified Overt Aggression Scale (OAS-M), and the Aberrant Be havior 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 w ith significant improvements on the CGI-S (p < .001) and the at-school ABC overall and hyperactivity scales (p < .05). During a 2 week washout followi ng the 6-week trial, a statistically significant worsening was found in the risperidone group on the CGI-S scale, the OASM, and the ABC. Extrapyramida l symptoms were absent or very mild during risperidone treatment. Transient tiredness was present in 11 (58%) of 19 drug-treated subjects. Other untow ard 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 bloo d pressure. Conclusion: These results suggest that risperidone may be effective for sev ere aggression in adolescents with disruptive behavior disorders and subave rage intelligence, and these results are consistent with reports suggesting its effectiveness for treating severe aggression in adolescents in general .