Efficacy Of N-Acetyl Cysteine In Autism: A Double-Blind, Placebo-Controlled Randomised Trial

Efficacy Of N-Acetyl Cysteine on Social Skills, Communication and Behaviour In Autistic Children: A Double-Blind, Placebo-Controlled Randomised Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000635066

Enrollment

Registered

2010-08-03

Start date

2011-06-01

Completion date

2013-04-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the antioxidant precursor, N-acetyl cysteine (NAC) as a treatment for children with autism. Recent evidence has shown children with autism to have imbalances in their antioxidant defences. The primary antioxidant in the brain, glutathione, has been shown to be decreased in these children. This study aims to increase the amount of available glutathione by administering NAC. The trial will be conducted in a total of 80 children, 40 of which will take the NAC treatment and the remaining 40 will take a matched placebo. The study will run over six months after which there will be a 12 and 18 month post-baseline follow up to determine the children’s symptoms following the trial. Standard rating scales will be used to assess the children at baseline, 1, 3, 6 and subsequently 12 and 18 months. Children will remain on any treatment regime they are currently taking part in. Treatment options are limited at present for children with autism and it is hoped that this trial will be efficacious and provide more options for these children.

Interventions

Oral N-acetyl cysteine (500 mg once a day) for a total of 24 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

3 Years to 10 Years

Healthy volunteers

Inclusion criteria

Meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Autistic Disorder. If on pharmacological therapies, participants must be on stable therapy for 2 weeks prior to commencing the trial

Exclusion criteria

Individuals with a primary diagnosis of Asperger’s Disorder, or other Pervasive Developmental Disorders. Children with a known or suspected clinically relevant systemic medical disorder. Children who have had a prior sensitivity or allergy to N-acetyl cysteine (NAC) or gluten (corn starch). Inability to comply with the treatment protocol, for example fussy restricted diet that may lead to refusal to take NAC. Parental non-fluency in English. History of epilepsy. Clinically relevant biochemical or haematological abnormalities at baseline.

Outcome results