title: Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study.
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.
authors.affiliation: Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, PO Box 200, Titusville, NJ 08560, USA. jkent@its.jnj.com
authors.forename: Justine M
authors.initials: JM
authors.lastname: Kent
authors.forename: Stuart
authors.initials: S
authors.lastname: Kushner
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Ning
authors.forename: Keith
authors.initials: K
authors.lastname: Karcher
authors.forename: Seth
authors.initials: S
authors.lastname: Ness
authors.forename: Michael
authors.initials: M
authors.lastname: Aman
authors.forename: Jaskaran
authors.initials: J
authors.lastname: Singh
authors.forename: David
authors.initials: D
authors.lastname: Hough
mesh_terms: D000293:Adolescent; D001321:Autistic Disorder / Q000175:diagnosis* / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D012702:Serotonin Antagonists; D018967:Risperidone