Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study.

Author(s): Kent JM(1), Kushner S, Ning X, Karcher K, Ness S, Aman M, Singh J, Hough D.

Affiliation(s): Author information: (1)Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, PO Box 200, Titusville, NJ 08560, USA. jkent@its.jnj.com

Publication date & source: 2013, J Autism Dev Disord. , 43(8):1773-83

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.