Folinic Acid as Adjunctive Therapy in Treatment of Inappropriate Speech in Children with Autism: A Double-Blind and Placebo-Controlled Randomized Trial.

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).

• Authors: Neda Batebi, Hossein Sanjari Moghaddam, Alireza Hasanzadeh, Yousef Fakour, Mohammad Reza Mohammadi, Shahin Akhondzadeh
• Journal: Child psychiatry and human development (Child Psychiatry Hum Dev) Vol. 52 Issue 5 Pg. 928-938 (10 2021) ISSN: 1573-3327 [Electronic] United States
• PMID: 33029705 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020. Springer Science+Business Media, LLC, part of Springer Nature.

Chemical References

• Antipsychotic Agents
• Leucovorin

Topics

• Antipsychotic Agents (therapeutic use)
• Autism Spectrum Disorder (drug therapy)
• Autistic Disorder (drug therapy)
• Child
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Iran
• Leucovorin (therapeutic use)
• Male
• Speech
• Treatment Outcome