A randomised, double blind, placebo-controlled trial of a fixed dose of <i>N</i>-acetyl cysteine in children with autistic disorder

Dean, Olivia; Gray, Kylie Megan; Villagonzalo, Kristi-Ann; Dodd, Seetal; Mohebbi, Mohammadreza; Vick, Tanya; Tonge, Bruce John; Berk, Michael

doi:10.1177/0004867416652735

Cited by 56 publications

(39 citation statements)

References 23 publications

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“…Most of the sample population were male (633 of 765). The mean age of study participants varied considerably: four studies evaluated treatment for adults (range 18-60) [30,31,37,39], while 10 involved evaluated interventions only for children and adolescents (range 2-18) [32][33][34][35][36][38][39][40][41][42][43]. The median duration of the treatment period was 12 weeks (range 6-24).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Among the 14 RCT studies found eligible, six found significant improvement as assessed by RRBs scales when comparing medication and placebo groups: two on risperidone [31,40]; one on fluvoxamine [30]; one on fluoxetine [39]; one on Buspirone [41] and, one divalproex sodium [33]. Six studies yielded negative results: one on nacetylcysteine [42]; one on oxytocin [43]; one on fluoxetine [32]; one on citalopram [36]; one levetiracetam [34]; and, one olanzapine [35]). Two studies showed a significant difference on only one of the two subscales of the RBS-R (stereotypies) of the two tools (RBS-R and Y-BOCS) used in the study: one oxytocin [31]; one N-Acetylcysteine [38] (See Table 1).…”

Section: Clinical Outcomementioning

confidence: 99%

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Pharmacotherapy of restricted/repetitive behavior in autism spectrum disorder:a systematic review and meta-analysis

Chaulagain

Pedersen

et al. 2020

BMC Psychiatry

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Background: This paper is a systematic review and meta-analysis of the efficacy of available medications for the treatment of restricted/repetitive behavior (RRBs) in Autism Spectrum Disorder (ASD). Method: We searched MEDLINE, Embase, PsycINFO, The Cochrane Library (Cochrane Database of Systematic Reviews (CDRS), the Cochrane Central Register of Controlled Trials (CENTRAL), database of Abstracts of Reviews of Effects (DARE)), Scopus, Epistimonikos, Clinicaltrials.gov, and included all randomized controlled trials published after 1993 that were directed at RRBs in patients with ASD of all ages. We extracted the relevant data from the published studies with a predefined data extraction form and assessed the risk of bias. The primary outcomes were change in restricted/repetitive behavior. We performed a meta-analysis using the random effect model and included studies with given mean and standard deviation. This study is registered with PROSPERO number CRD42018092660). Results: We identified 14 randomized controlled trials that met initial inclusion criteria. After closer inspection, nine trialsinvolving 552 patients in totalwere included in the final analysis. The meta-analysis found no significant difference between medications (including fluvoxamine, risperidone, fluoxetine, citalopram, oxytocin, N-Acetylcysteine, buspirone) and placebo in the treatment of RRBs in ASD (P = 0.20). Similarly, the subgroup metaanalysis also showed no significant difference between Selective Serotonin Reuptake Inhibitor (SSRIs) and placebo in the treatment of RRBs in ASD (P = 0.68). There was no evidence of publication bias. Conclusion: This meta-analysis finds little support for the routine use of medications to treat restricted/repetitive behaviors in Autism Spectrum Disorder. Further research of large, balanced trials with precise assessment tools and long-term follow-up are needed. Trial registration: The study protocol is registered in PROSPERO (Reference number: CRD42018092660).

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Clinical Outcomementioning

confidence: 99%

Pharmacotherapy of restricted/repetitive behavior in autism spectrum disorder:a systematic review and meta-analysis

Chaulagain

Pedersen

et al. 2020

BMC Psychiatry

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“…In a sample size of 32 children, research showed that arbaclofen was helpful in alleviating social withdrawal and irritability. Another GABA agent, N-acetylcysteine, works by targeting the GABA pathway and decreases glutamatergic neurotransmission and has been shown to alleviate symptoms of irritability (Dean et al, 2017;Stahl, 2017).…”

Section: Gaba Agentsmentioning

confidence: 99%

Neurological Differences and Pharmaceuticals in Persons with Autism

Barnhart

2019

ijmsci

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Given the rise of persons diagnosed with autism, this paper is to highlight psychopharmacueticals that are often used in the treatment of autism symptomology. I begin with a brief summary of autism followed by a summation of biological differences. A discussion of pharmaceuticals often used to alleviate the symptoms associated with autism is also discussed. Lastly, a brief conclusory statement is provided.

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“…Additionally, 2 randomized, placebo-controlled trials of NAC in conjunction with risperidone for the treatment of irritability in patients with ASD (with 50 and 40 participants, respectively) showed a significant reduction in the ABC irritability subscale score in the NAC-treated groups [184,185]. More recently, 2 other randomized, placebo-controlled trials found no benefit of NAC in children with autism [186,187].…”

Section: Supplementsmentioning

confidence: 99%

Immunological Dysfunction in Autism Spectrum Disorder: A Potential Target for Therapy

Marchezan

Santos

Deckmann

et al. 2018

Neuroimmunomodulation

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Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder with an unknown etiology and currently few effective therapies. Immune system alterations have being demonstrated in ASD, both in humans and via animal models; immune imbalance thus arises as a possible pathway for drug intervention. In this review, the studies were classified into 2 major groups: (1) clinical research whose authors classify therapies with primary anti-inflammatory and immunomodulatory actions, making use of: sulforaphane, celecoxib, lenalidomide, pentoxifylline, spironolactone, flavonoid luteolin, corticosteroids, oral immunoglobulin, intravenous immunoglobulin, cell therapy, dialyzable lymphocyte extracts, minocycline, and pioglitazone; and (2) other ASD therapies already used or currently under study whose initial characteristics were neither anti-inflammatory nor immunomodulatory initially, but displayed a capacity for immunomodulation throughout the treatment: risperidone, vitamin D, omega-3, Ginkgo biloba, L-carnosine, N-acetylcysteine, and microbiome restoration. These studies used various data acquisition methodologies. Questions arose such the need for randomized and placebo-controlled studies with greater numbers of participants as well as the use of biomarkers to refine the treatment of autistic subjects.

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A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder

Abstract: This study failed to demonstrate any benefit of adjunctive N-acetyl cysteine in treating autistic disorder. While this may reflect a true null result, methodological issues particularly the lower dose utilised in this study may be confounders.

Cited by 56 publications

References 23 publications

Pharmacotherapy of restricted/repetitive behavior in autism spectrum disorder:a systematic review and meta-analysis

Pharmacotherapy of restricted/repetitive behavior in autism spectrum disorder:a systematic review and meta-analysis

Neurological Differences and Pharmaceuticals in Persons with Autism

Immunological Dysfunction in Autism Spectrum Disorder: A Potential Target for Therapy

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