title: A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone: Effects on aberrant behavior in children with autism.
abstract: To assess the safety and efficacy of pioglitazone added to risperidone in the treatment of irritability in autistic disorder (AD), we conducted this study. In a 10-week, randomized, double-blind, parallel-group, placebo-controlled clinical trial, 44 outpatients of both genders aged 4-12 years with a diagnosis of AD and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale were included. Mean change of ABC-C irritability subscale score as primary outcome, change in other ABC-C subscale scores and partial and complete responses were compared between two groups. Twenty patients completed the trial in each group. Level of reduction and effect of time×treatment interaction in the treatment group were significant for irritability (P=0.03), lethargy/social withdrawal (P=0.04) and hyperactivity/non-compliance (P=0.03) but not for stereotypic behavior and inappropriate speech subscales compared with the placebo group. Vomiting and headache were the most frequent reported side-effects. Results of this preliminary study indicate positive effects of pioglitazone compared with placebo in improving the behavioral symptoms of AD.
authors.affiliation: Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Ghaleiha
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran.
authors.forename: Soudeh Mohebbi
authors.initials: SM
authors.lastname: Rasa
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran.
authors.forename: Mohammadali
authors.initials: M
authors.lastname: Nikoo
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran.
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Mohammadi
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran. Electronic address: s.akhond@neda.net.
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage; D001321:Autistic Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D008297:Male; D010865:Pilot Projects; D000077205:Pioglitazone; D018967:Risperidone / Q000008:administration & dosage*; D045162:Thiazolidinediones / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D045162:Thiazolidinediones; D018967:Risperidone; D000077205:Pioglitazone
keywords: Autistic Disorder; Inflammation; Pioglitazone; Risperidone