title: Risperidone in children with autism and serious behavioral problems.
abstract: BACKGROUND
  Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited.
  
  
  METHODS
  We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks.
  
  
  RESULTS
  A total of 101 children (82 boys and 19 girls; mean [+/-SD] age, 8.8+/-2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7+/-2.9 kg, as compared with 0.8+/-2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P<0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months.
  
  
  CONCLUSIONS
  Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.
authors.affiliation: University of California, Los Angeles, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: James
authors.initials: J
authors.lastname: McGough
authors.forename: Bhavik
authors.initials: B
authors.lastname: Shah
authors.forename: Pegeen
authors.initials: P
authors.lastname: Cronin
authors.forename: Daniel
authors.initials: D
authors.lastname: Hong
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.forename: Ronald
authors.initials: R
authors.lastname: Lindsay
authors.forename: Patricia
authors.initials: P
authors.lastname: Nash
authors.forename: Jill
authors.initials: J
authors.lastname: Hollway
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: McDougle
authors.forename: David
authors.initials: D
authors.lastname: Posey
authors.forename: Naomi
authors.initials: N
authors.lastname: Swiezy
authors.forename: Arlene
authors.initials: A
authors.lastname: Kohn
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: Andres
authors.initials: A
authors.lastname: Martin
authors.forename: Kathleen
authors.initials: K
authors.lastname: Koenig
authors.forename: Fred
authors.initials: F
authors.lastname: Volkmar
authors.forename: Deirdre
authors.initials: D
authors.lastname: Carroll
authors.forename: Allison
authors.initials: A
authors.lastname: Lancor
authors.forename: Elaine
authors.initials: E
authors.lastname: Tierney
authors.forename: Jaswinder
authors.initials: J
authors.lastname: Ghuman
authors.forename: Nilda M
authors.initials: NM
authors.lastname: Gonzalez
authors.forename: Marco
authors.initials: M
authors.lastname: Grados
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.forename: Louise
authors.initials: L
authors.lastname: Ritz
authors.forename: Mark
authors.initials: M
authors.lastname: Davies
authors.forename: James
authors.initials: J
authors.lastname: Robinson
authors.forename: Don
authors.initials: D
authors.lastname: McMahon
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002652:Child Behavior / Q000187:drug effects; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone