Short-term efficacy and safety of risperidone in young children with autistic disorder (AD).

Recently, atypical antipsychotic treatments have been used in children with autistic disorder (AD). However, data on safety and efficacy of atypical antipsychotic agents in autistic children are limited. In this open, prospective trial, subjects were treated with risperidone for six weeks. Nineteen children (12 male, 7 female) aged 4 to 8 years were started on 0.5 mg daily with individual titration to a maximum of 1.5 mg daily. Behavioural assessments were completed by Conner's parent 10-item index, AD symptom checklist and CGI-Global improvement. Statistically significant improvement was observed in mean total scores of Conner's parent 10-item index from baseline to the end of study (p< 0.001). On the basis of the CGI-Global improvement item, 15 children were considered responders. Statistically significant improvement was also found in some aspects of social contact, impulsive-aggression and repetitive, ritualistic behaviour based on assessment with the AD-symptom checklist. Weight gain and increase in night-time sleep were the most frequent side effects.