Prednisolone As Adjunctive Treatment to Risperidone in Children With Regressive Type of Autism Spectrum Disorder: A Randomized, Placebo-Controlled Trial Publisher Pubmed



Malek M¹ ; Ashrafganjouei A¹ ; Moradi K¹ ; Bagheri S¹ ; Mohammadi MR¹ ; Akhondzadeh S¹ Show Affiliations
Source: Clinical Neuropharmacology Published:2020

Abstract

Objectives This study aimed to evaluate efficacy and safety of prednisolone as an adjunctive treatment to risperidone, in children with regressive autism spectrum disorder (ASD). Methods The current 12-week, randomized, single-blinded, placebo-controlled trial recruited 37 patients with regressive ASD. The participants were allocated to receive either 1 mg/kg per day prednisolone or matched placebo in addition to risperidone. The Aberrant Behavior Checklist-Community Edition (ABC-C) scale and Childhood Autism Rating Scale (CARS) were used to measure behavioral outcomes at weeks 0, 4, 8, and 12 of the study course. The primary outcome was the change in ABC-irritability subscale score, whereas the secondary outcomes were the change in scores of other ABC-C subscales, in CARS score, and in the level of inflammatory biomarkers. Results Twenty-six patients completed the 12 weeks of study period. Repeated-measures analysis demonstrated significant effect for time-treatment interaction in the CARS (F (1, 2.23) = 13.22, P < 0.001), as well as 4 subscales of the ABC-C including: irritability (F (1, 2.12) = 3.84, P = 0.026), hyperactivity (F (1, 2.09) = 3.56, P = 0.039), lethargy (F (1, 2.18) = 31.50, P < 0.001), and stereotypy (F (1, 1.89) = 4.04, P = 0.026). However, no significant time-treatment interaction was identified for inappropriate speech subscale (F (1, 2.03) = 1.71, P = 0.191). In addition, inflammatory biomarkers were significantly decreased after 3 months of prednisolone add-on. No significant adverse event was detected during the trial. Conclusions Prednisolone, as an add-on to risperidone, could remarkably improve core features in children with regressive ASD. © Wolters Kluwer Health, Inc. All rights reserved.