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RecruitingPhase 2NCT04278898

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

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Trial Parameters

ConditionAutism Spectrum Disorder
SponsorStanford University
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment24
SexALL
Min Age3 Years
Max Age12 Years
Start Date2021-02-12
Completion2028-07-31
Interventions
N-Acetylcysteine

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Brief 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 Criteria: * children between 3 years and 12 years 11 months at the time of consent * 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 Scale- Second 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

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