title: Double-blind, placebo-controlled trial of risperidone plus topiramate in children with autistic disorder.
abstract: BACKGROUND
  Autism is a complex neurodevelopmental disorder that forms part of a spectrum of related disorders referred to as Autism Spectrum Disorders. The present study assessed the effects of topiramate plus risperidone in the treatment of autistic disorder.
  
  
  METHODS
  Forty children between the ages of 4 and 12 years with a DSM IV clinical diagnosis of autism who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to topiramate+risperidone (Group A) or placebo+risperidone (Group B) for an 8-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of topiramate was titrated up to 200 mg/day depending on weight (100 mg/day for <30 kg and 200 mg/day for >30 kg). Patients were assessed at baseline and after 2, 4, 6 and 8 weeks after starting medication. Measure of outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale.
  
  
  RESULTS
  Difference between the two protocols was significant as the group that received topiramate had a greater reduction in ABC-C subscale scores for irritability, stereotypic behavior and hyperactivity/noncompliance.
  
  
  CONCLUSIONS
  The results suggest that the combination of topiramate with risperidone may be superior to risperidone monotherapy for children with autistic disorder. However the results need to be further confirmed by a larger randomized controlled trial.
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Hafez Hospital, Shiraz, Iran.
authors.forename: Vala
authors.initials: V
authors.lastname: Rezaei
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Mohammadi
authors.forename: Ahmad
authors.initials: A
authors.lastname: Ghanizadeh
authors.forename: Ali
authors.initials: A
authors.lastname: Sahraian
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Shams-Ali
authors.initials: SA
authors.lastname: Rezazadeh
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D012189:Retrospective Studies; D018967:Risperidone / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose; D018967:Risperidone