Rosiglitazone Adjunct to Risperidone for Irritability in Autistic Children: A Randomized, Double-Blind, Placebo-Controlled Trial Publisher Pubmed



Bayan N ; Bayan N ; Mokhtari F ; Shamabadi A ; Hasanzadeh A ; Hasanzadeh M ; Karkhanehyousefi A ; Mohammadi M ; Akhondzadeh S
Source: Journal of Autism and Developmental Disorders Published:2025

Abstract

Purpose: This randomized, ten-week, double-blind, placebo-controlled clinical trial assessed rosiglitazone, an anti-diabetic agent with neuroprotective and anti-inflammatory effects, for irritability in autism spectrum disorder (ASD). Methods: 70 participants were allocated to receive either rosiglitazone 2 mg b.i.d. or placebo in addition to risperidone and were evaluated for the Aberrant Behavior Checklist-Community Scale (ABC-C), the Extrapyramidal Symptom Rating Scale, and side effects at baseline and weeks 5 and 10. Results: The baseline characteristics were comparable (Ps > 0.05). There were significant time-treatment interaction effects on the irritability subscale ABC-C scores (= 0.054). Also, the mean reductions in irritability scores to the endpoint were significantly greater in the rosiglitazone group (Cohen’s d = 0.609). However, the score changes in other subscales were similar between the groups (Ps > 0.05). Using rosiglitazone did not cause significantly different adverse effects. Conclusion: Rosiglitazone was beneficial for reducing irritability in autistic children in a safe and tolerable manner. The interpretation of these benefits is limited by modest sample size and short duration. Clinical Trial Registration: This trial was prospectively registered in the Iranian Registry of Clinical Trials on 2023-04-24 (IRCT20090117001556N150). © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2025.