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

Dean, Olivia M., Gray, Kylie M., Villagonzalo, Kristi-Ann, Dodd, Seetal, Mohebbi, Mohammadreza, Vick, Tanya, Tonge, Bruce J. and Berk, Michael 2016, A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder, Australian and New Zealand journal of psychiatry, In press, pp. 1-9, doi: 10.1177/0004867416652735.

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Title A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder
Author(s) Dean, Olivia M.
Gray, Kylie M.
Villagonzalo, Kristi-Ann
Dodd, Seetal
Mohebbi, Mohammadreza
Vick, Tanya
Tonge, Bruce J.
Berk, Michael
Journal name Australian and New Zealand journal of psychiatry
Season In press
Start page 1
End page 9
Total pages 9
Publisher Sage
Place of publication London, Eng.
Publication date 2016-06-17
ISSN 1440-1614
Keyword(s) Autism
acetyl cysteine
clinical trial
spectrum
Summary OBJECTIVE: Oxidative stress, inflammation and heavy metals have been implicated in the aetiology of autistic disorder. N-acetyl cysteine has been shown to modulate these pathways, providing a rationale to trial N-acetyl cysteine for autistic disorder. There are now two published pilot studies suggesting efficacy, particularly in symptoms of irritability. This study aimed to explore if N-acetyl cysteine is a useful treatment for autistic disorder.

METHOD: This was a placebo-controlled, randomised clinical trial of 500 mg/day oral N-acetyl cysteine over 6 months, in addition to treatment as usual, in children with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of autistic disorder. The study was conducted in Victoria, Australia. The primary outcome measures were the Social Responsiveness Scale, Children's Communication Checklist-Second Edition and the Repetitive Behavior Scale-Revised. Additionally, demographic data, the parent-completed Vineland Adaptive Behavior Scales, Social Communication Questionnaire and clinician-administered Autism Diagnostic Observation Schedule were completed.

RESULTS: A total of 102 children were randomised into the study, and 98 (79 male, 19 female; age range: 3.1-9.9 years) attended the baseline appointment with their parent/guardian, forming the Intention to Treat sample. There were no differences between N-acetyl cysteine and placebo-treated groups on any of the outcome measures for either primary or secondary endpoints. There was no significant difference in the number and severity of adverse events between groups.

CONCLUSION: 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.
Language eng
DOI 10.1177/0004867416652735
Field of Research 110319 Psychiatry (incl Psychotherapy)
111714 Mental Health
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, Royal Australian and New Zealand College of Psychiatrists
Persistent URL http://hdl.handle.net/10536/DRO/DU:30084434

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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