title: Risperidone improves behavioral symptoms in children with autism in a randomized, double-blind, placebo-controlled trial.
abstract: Subgroup analysis of children (5-12 years) with autism enrolled in an 8-week, double-blind, placebo-controlled trial of risperidone for pervasive developmental disorders. The primary efficacy measure was the Aberrant Behavior Checklist-Irritability (ABC-I) subscale. Data were available for 55 children given risperidone (n=27) or placebo (n=28); mean baseline ABC-I ( +/- SD) was 20.6 (8.1) and 21.6 (10.2). Risperidone [mean dose ( +/- SD): 1.37 mg/day (0.7)] resulted in significantly greater reduction from baseline to endpoint in ABC-I versus placebo [mean change ( +/- SD): -13.4 (1.5) vs. -7.2 (1.4), P<0.05; ES=-0.7]. The most common adverse effect with risperidone was somnolence (74% vs. 7% with placebo). Risperidone treatment was well tolerated and significantly improved behavioral problems associated with autism.
authors.affiliation: Medical Affairs, Janssen Pharmaceutica, Inc., Titusville, NJ 08560, USA. gpandina@janus.jnj.com
authors.forename: Gahan J
authors.initials: GJ
authors.lastname: Pandina
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Bossie
authors.forename: Eriene
authors.initials: E
authors.lastname: Youssef
authors.forename: Young
authors.initials: Y
authors.lastname: Zhu
authors.forename: Fiona
authors.initials: F
authors.lastname: Dunbar
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000453:epidemiology*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019964:Mood Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D011596:Psychomotor Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D018967:Risperidone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone