An open trial of risperidone in young autistic children.

OBJECTIVE

To assess the benefits and side effects of risperidone in young autistic children.

METHOD: In this open, prospective trial, subjects were treated with risperidone for 12 weeks. All subjects were started at 0.5 mg daily with individual titration to a maximum of 6 mg or 0.1 mg/kg daily. Behavioral ratings, completed by the investigators and the children's parents, included the Clinical Global Impressions (CGI), Children's Psychiatric Rating Scale, Conners Parent-Teacher Questionnaire, Childhood Autism Rating Scale, and Abnormal Involuntary Movement Scale.

RESULTS

Ten boys, aged 4.5 to 10.8 years, were enrolled in the study and all completed the 12-week protocol. The mean final dose was 1.3 mg/day (range = 1 to 2.5 mg/day). On the basis of CGI-rated improvement, 8 of the 10 children were considered to be responders. Improvement was also demonstrated on the other scales. Transient sedation was common, and the children gained an average of 3.5 kg over the 12 weeks of the study. There was no evidence of either extrapyramidal symptoms or tardive dyskinesia.

CONCLUSIONS

These results suggest that risperidone may be safe and leads to improvements in several behavioral symptoms in young children with autism. Controlled studies of risperidone in young autistic children are warranted.