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. Attached Files Name Description MIMEType Size Downloads 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. orcid.org/0000-0002-2776-3935 Gray, Kylie M. Villagonzalo, Kristi-Ann Dodd, Seetal orcid.org/0000-0002-7918-4636 Mohebbi, Mohammadreza Vick, Tanya Tonge, Bruce J. Berk, Michael orcid.org/0000-0002-5554-6946 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 Related Links Link Description Connect to Elements publication management system Go to link with your DU access privileges   Connect to published version Go to link with your DU access privileges     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Versions Version Filter Type Tue, 28 Jun 2016, 11:32:54 EST Wed, 29 Jun 2016, 05:01:05 EST Wed, 06 Jul 2016, 06:09:38 EST Fri, 12 Aug 2016, 13:22:03 EST Fri, 12 Aug 2016, 13:28:38 EST Thu, 18 Aug 2016, 10:04:41 EST Tue, 24 Jan 2017, 14:10:55 EST Sat, 04 Mar 2017, 01:32:08 EST Sat, 15 Apr 2017, 02:36:14 EST Filtered Full Citation counts:   Cited 1 times in TR Web of Science Cited 1 times in Scopus Search Google Scholar Access Statistics: 130 Abstract Views, 3 File Downloads  -  Detailed Statistics Created: Tue, 28 Jun 2016, 11:32:54 EST

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