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

Phase

Condition

Asperger's Disorder

Autism

Williams Syndrome

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