, Volume 43, Issue 8, pp 1773-1783

Risperidone Dosing in Children and Adolescents with Autistic Disorder: A Double-Blind, Placebo-Controlled Study

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Abstract

Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N = 96; 5–17 years), received risperidone (low-dose: 0.125 mg/day [20 to <45 kg], 0.175 mg/day [>45 kg] or high-dose: 1.25 mg/day [20 to <45 kg], 1.75 mg/day [>45 kg]) 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.

These data were presented at the 58th Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) Toronto, October 18–23, 2011.
Registration: This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).