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.
