Abstract

Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N=96; 5-17years), received risperidone (low-dose: 0.125mg/day [20 to <45kg], 0.175mg/day [>45kg] or high-dose: 1.25mg/day [20 to <45kg], 1.75mg/day [>45kg]) or placebo. Mean baseline (range 27-29) to endpoint change in Aberrant Behavior Checklist-Irritability (primary endpoint) was significantly greater in the high-dose-(-12.4 [6.5]; p<0.001), but not low-dose (-7.4 [8.1]; p=0.164) group, versus placebo (-3.5 [10.7]). Clinical Global Impressions-Severity and Children's Yale-Brown Obsessive Compulsive Scale scores improved significantly only in the high-dose group, consistent with ABC-I results. Somnolence, sedation and increased appetite occurred more frequently in high-versus low-dose groups. Overall, increased appetite occurred most frequently.

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