title: A randomized double-blind placebo-controlled clinical trial of adjuvant buspirone for irritability in autism.
abstract: BACKGROUND
  The brain serotonin level is decreased in individuals with autism. Buspirone is a 5-HT(1A) receptor agonist with antiaggressive effects increasing prosocial behaviors.
  
  
  METHODS
  We conducted an 8-week randomized double-blind placebo-controlled clinical trial. Participants included 40 outpatient children and adolescents with autism. The patients took buspirone plus risperidone or risperidone plus placebo during 8 weeks. The patients were assessed at baseline, week 4, and week 8 using the Aberrant Behavior Checklist-Community Rating Scale.
  
  
  RESULTS
  Eighteen patients in the placebo group and 16 patients in the buspirone group completed this trial. The mean dose of buspirone was 6.7 (SD 2.7) mg/day. Irritability subscale score significantly decreased during this trial in both groups (buspirone group: declined from 25.7 [SD 5.7] to 16.3 [SD 8.5]; placebo group: declined from 24.7 [SD 7.6] to 18.2 [SD 7.7]). The Cohen d effect size was .45. Thirteen (81.2%) of 16 patients in the buspirone group and 7 (38.9%) of 18 patients in the placebo group showed a ≥30% decline in irritability score. The relative risk for treatment was 2.1. There were no serious adverse effects. The most common adverse effects in the buspirone group were increased appetite, drowsiness, and fatigue.
  
  
  CONCLUSIONS
  This clinical trial supports that low dose buspirone plus risperidone is more effective than risperidone plus placebo for treating irritability in individuals with autism.
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Neuroscience, School of Advanced Medical Sciences and Technologies, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ghanizad@sina.tums.ac.ir.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Ghanizadeh
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Anaheed
authors.initials: A
authors.lastname: Ayoobzadehshirazi
mesh_terms: D000553:Ambulatory Care; D001321:Autistic Disorder / Q000188:drug therapy* / Q000523:psychology*; D002065:Buspirone / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects*; D008297:Male; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D018967:Risperidone / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D011619:Psychotropic Drugs; D018967:Risperidone; D002065:Buspirone
keywords: autism; buspirone; irritability; risperidone; serotonin