title: Double-blind, placebo-controlled trial of risperidone plus amantadine in children with autism: a 10-week randomized study.
abstract: OBJECTIVE
  This study aimed to investigate the effect of adding amantadine to risperidone for treatment of autism.
  
  
  METHODS
  Forty outpatients aged 4 to12 years, who were diagnosed with autism spectrum disorders based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, were assigned to this double-blind clinical trial. The subjects were divided randomly into 2 groups. One group received risperidone plus amantadine, and the other group received risperidone plus placebo. The dose of risperidone was titrated between 1 and 2.0 mg/d, and the dose of amantadine was 100 or 150 mg/d for patients less than 30 kg or more than 30 kg, respectively. The patients were assessed using the Aberrant Behavioral Checklist-Community (ABC-C) and adverse effects checklist as well as clinical global impression-improvement (CGI-I) at2 checkpoints of 5-week intervals after the baseline. Informed consentwas obtained from the parents of each participant.
  
  
  RESULTS
  Among ABC-C subscales, Hyperactivity and Irritability showed significantly greater reduction in the amantadine group than the placebo group. There was no significant difference in adverse effects between the 2 groups. The CGI-I scores show significant improvement in the amantadine group compared to the placebo group.
  
  
  CONCLUSIONS
  The present study suggests that amantadine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated.
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Mohammadi
authors.forename: Nourrollah
authors.initials: N
authors.lastname: Yadegari
authors.forename: Elmira
authors.initials: E
authors.lastname: Hassanzadeh
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.forename: Habibeh
authors.initials: H
authors.lastname: Yekehtaz
authors.forename: Omid
authors.initials: O
authors.lastname: Mirshafiee
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000547:Amantadine / Q000008:administration & dosage*; D001321:Autistic Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D002648:Child; D002675:Child, Preschool; D015259:Dopamine Agents / Q000008:administration & dosage*; D018492:Dopamine Antagonists / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects* / Q000502:physiology; D008297:Male; D018967:Risperidone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D015259:Dopamine Agents; D018492:Dopamine Antagonists; D000547:Amantadine; D018967:Risperidone