Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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 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 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.