Folinic Acid as Adjunctive Therapy in Treatment of Inappropriate Speech in Children with Autism: A Double-Blind and Plac
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ORIGINAL ARTICLE
Folinic Acid as Adjunctive Therapy in Treatment of Inappropriate Speech in Children with Autism: A Double-Blind and PlaceboControlled Randomized Trial Neda Batebi1 · Hossein Sanjari Moghaddam1 · Alireza Hasanzadeh1 · Yousef Fakour1 · Mohammad Reza Mohammadi1 · Shahin Akhondzadeh1,2 Accepted: 30 September 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
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). Keywords Autism spectrum disorder · Inappropriate speech · Aberrant behavior checklist-community · Folate metabolism · Folinic acid
Introduction Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders in early childhood, affecting approximately 2.47% of children and adolescents in the United States [1, 2]. The clinical symptoms of ASD are generally categorized into core and associated symptoms. The core Neda Batebi, Hossein Sanjari Moghaddam and Alireza Hasanzadeh have contributed equallt to this study. * Shahin Akhondzadeh [email protected] 1
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337 Tehran, Iran
2
symptoms of ASD include social communication impairments and inappropriate, restrictive, and stereotypic behavior. In contrast, the main associated symptoms of ASD are irritability, hyperactivity, aggressiveness, and cognitive deficits [3–7]. Among the associated symptoms, management of inappropriate speech has gained significant attention as it complicates development, learning, and communication of ASD children, necessitating its pharmaco
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