Status:
RECRUITING
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
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 supplem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04278898
Start Date
February 12 2021
End Date
January 1 2027
Last Update
August 26 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305