Psychiatry - Theses
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ItemRedox biology and autism( 2016)Background: Evidence suggests that oxidative stress may be related to the aetiology of autism. This is supported by studies showing deficiencies in glutathione and other antioxidants, mitochondrial dysfunction and genetic links between autism and abnormalities in redox biology. Glutathione, an important cellular antioxidant, is therefore proposed as a potential treatment target in autism. N-acetyl cysteine (NAC), a glutathione precursor, may be an effective method of supplementing glutathione levels, and thus improving behavioural symptoms and functioning, in children with autism. Method: This study was a mixed-methods, double-blind, randomised, placebo-controlled clinical trial of 500 mg daily NAC, in addition to treatment as usual, for 6 months in children with autistic disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, revised. The primary outcomes were the core symptoms of autistic disorder: social interaction, as measured by the Social Responsiveness Scale; communication, as measured by the Children’s Communication Checklist – Second Edition; and restricted and repetitive behaviours and interests, as measured by the Repetitive Behavior Scale – Revised. Secondary outcomes were problem behaviours, as measured by the Developmental Behaviour Checklist – Primary Carer Version; adaptive functioning, as measured by the Vineland Adaptive Behavior Scales – Second Edition; and parent and clinician global impression scales. In addition, qualitative analysis of parent/guardian reports and clinicians’ observations was carried out to supplement the main efficacy study. Results: A total of 98 children (79 male, 19 female; age range = 3.1-10.1 years) were enrolled into the study, of whom 48 were randomised to receive NAC and 50 were randomised to receive placebo. The NAC and placebo groups did not differ on any demographic or baseline symptom severity measure. Seventy-one participants (34 from NAC group, 37 from placebo group) completed the 6-month trial. NAC did not differ from placebo on safety and tolerability. There were no differences between the NAC and placebo groups on any primary or secondary outcome measures. In contrast, the qualitative analysis found that NAC was associated with more frequent reports of improved calmness and verbal communication than placebo. Conclusions: This study found that NAC was not effective in improving core symptoms or functioning in children with autism, as assessed by a range of comprehensive quantitative measures. However, this study did demonstrate the potential utility of mixed-methods approaches in autism treatment trials. Overall, this study does not support the widespread use of NAC for autism, although questions remain regarding dosage, and effects on specific symptoms within the broader clinical picture.