Original Paper

Journal of Autism and Developmental Disorders

, Volume 43, Issue 8, pp 1773-1783

First online:

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

  • Justine M. KentAffiliated withJanssen Research & Development, LLC Email author 
  • , Stuart KushnerAffiliated withJanssen Research & Development, LLCCFG Health Systems
  • , Xiaoping NingAffiliated withJanssen Research & Development, LLCPurdue Pharma
  • , Keith KarcherAffiliated withJanssen Research & Development, LLC
  • , Seth NessAffiliated withJanssen Research & Development, LLC
  • , Michael AmanAffiliated withThe Nisonger Center-UCEDD, Ohio State University
  • , Jaskaran SinghAffiliated withJanssen Research & Development, LLC
  • , David HoughAffiliated withJanssen Research & Development, LLC

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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.


Autistic disorder Double-blind Placebo-controlled Risperidone