Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study

  • End date
    Jan 23, 2024
  • participants needed
  • sponsor
    Stanford University
Updated on 23 September 2022


The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC.

Condition Autism Spectrum Disorder
Treatment N-acetylcysteine
Clinical Study IdentifierNCT04278898
SponsorStanford University
Last Modified on23 September 2022


Yes No Not Sure

Inclusion Criteria

aged between 3 years and 12 years 11 months
diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating ScaleSecond Edition (CARS-2)
at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11
physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1
medically stable
passes MR safety screening (e.g., no metal in the body)

Exclusion Criteria

presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X)
current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
presence of significant medical problems that would interfere with participation
the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials
individuals taking antioxidant agents and glutathione prodrugs, or
the inability/unwillingness to swallow an agent during the screening visit
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