Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose

Last updated: July 23, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

2

Condition

Asperger's Disorder

Autism

Autism Spectrum Disorder (Asd)

Treatment

N-Acetylcysteine

Clinical Study ID

NCT04278898
IRB-54931
1K99HD101702
  • Ages 3-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • children between 3 years and 12 years 11 months at the time of consent

  • diagnosis of Autism Spectrum Disorder confirmed with the Autism DiagnosticInterview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2),or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale-Second Edition (CARS-2).

  • at least moderate Restricted and Repetitive Behaviors severity defined by aChildren's Yale-Brown Obsessive Compulsive Scale for children with autism spectrumdisorder score ≥ 11,

  • physical development indicative of prepubescence as defined by the criteria forTanner Stage 1,

  • medically stable,

  • passes MR safety screening (e.g., no metal in the body).

Exclusion

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 levelto complete study requirements and materials,

  • individuals taking antioxidant agents and glutathione prodrugs, or

  • the inability/unwillingness to swallow an agent during the screening visit.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: N-Acetylcysteine
Phase: 2
Study Start date:
February 12, 2021
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Active - Recruiting

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