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

  • STATUS
    Recruiting
  • End date
    Jan 23, 2024
  • participants needed
    24
  • sponsor
    Stanford University
Updated on 23 September 2022

Summary

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.

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

Eligibility

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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