A Pilot Double-Blind Placebo-Controlled Trial of Pioglitazone As Adjunctive Treatment to Risperidone: Effects on Aberrant Behavior in Children With Autism Publisher Pubmed



Ghaleiha A¹ ; Rasa SM² ; Nikoo M² ; Farokhnia M² ; Mohammadi MR² ; Akhondzadeh S² Show Affiliations
Source: Psychiatry Research Published:2015

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. © 2015 Elsevier Ireland Ltd.