Folinic Acid As Adjunctive Therapy in Treatment of Inappropriate Speech in Children With Autism: A Double-Blind and Placebo-Controlled Randomized Trial Publisher Pubmed



Batebi N¹ ; Moghaddam HS¹ ; Hasanzadeh A¹ ; Fakour Y¹ ; Mohammadi MR¹ ; Akhondzadeh S^{1, 2} Show Affiliations
Source: Child Psychiatry and Human Development Published:2021

Abstract

This is a double-blind, placebo-controlled randomized trial to investigate the potential therapeutic effects of folinic acid/placebo as an adjuvant to risperidone on inappropriate speech and other behavioral symptoms of autism spectrum disorder (ASD). Fifty-five ASD children (age (mean ± standard deviation) = 13.40 ± 2.00; male/female: 35/20) were evaluated for behavioral symptoms at baseline, week 5, and week 10 using the aberrant behavior checklist-community (ABC-C). Folinic acid dosage was 2 mg/kg up to 50 mg per day for the entire course of the study. The repeated measures analysis showed significant effect for time × treatment interaction on inappropriate speech (F = 3.51; df = 1.61; P = 0.044), stereotypic behavior (F = 4.02; df = 1.37; P = 0.036), and hyperactivity/noncompliance (F = 6.79; df = 1.66; P = 0.003) subscale scores. In contrast, no significant effect for time × treatment interaction was found on lethargy/social withdrawal (F = 1.06; df = 1.57; P = 0.336) and irritability (F = 2.86; df = 1.91; P = 0.064) subscale scores. Our study provided preliminary evidence suggesting that folinic acid could be recommended as a beneficial complementary supplement for alleviating speech and behavioral symptoms in children with ASD. Clinical trial registeration: This trial was registered in the Iranian Registry of Clinical Trials (www.irct.ir; No. IRCT20090117001556N114). © 2020, Springer Science+Business Media, LLC, part of Springer Nature.