Double-blind, placebo-controlled trial of risperidone plus topiramate in children with autistic disorder

Prog Neuropsychopharmacol Biol Psychiatry. 2010 Oct 1;34(7):1269-72. doi: 10.1016/j.pnpbp.2010.07.005. Epub 2010 Jul 14.

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.

Method: 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.

Conclusion: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antipsychotic Agents / therapeutic use*
  • Autistic Disorder / drug therapy*
  • Autistic Disorder / physiopathology
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Therapy, Combination / methods
  • Female
  • Fructose / analogs & derivatives*
  • Fructose / therapeutic use
  • Humans
  • Male
  • Neuroprotective Agents / therapeutic use*
  • Neuropsychological Tests
  • Psychiatric Status Rating Scales
  • Retrospective Studies
  • Risperidone / therapeutic use*
  • Severity of Illness Index
  • Topiramate
  • Treatment Outcome

Substances

  • Antipsychotic Agents
  • Neuroprotective Agents
  • Topiramate
  • Fructose
  • Risperidone