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

Launched by STANFORD UNIVERSITY · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a nutritional supplement called N-acetylcysteine (NAC) on children with autism spectrum disorder (ASD), specifically looking at its impact on restricted and repetitive behaviors, which are common in children with ASD. The study aims to understand how NAC works and whether it can help reduce these behaviors. It will last for 12 weeks and involves a method called a double-blind, randomized, placebo-controlled trial, meaning neither the participants nor the researchers will know who is receiving the actual supplement versus a placebo (a non-active substance) during the study.

To be eligible for the trial, children must be between 3 and 12 years old and have a confirmed diagnosis of autism. They should show moderate to severe restricted and repetitive behaviors. Participants will need to have stable medication and treatment plans for a certain amount of time before joining the study. Additionally, children must live within 300 miles of the study site and pass certain safety screenings. Throughout the trial, participants will receive close monitoring and support, and their caregivers will need to be able to communicate in English. This study is currently recruiting participants, and it offers a chance for families to contribute to important research that could improve understanding and treatment of autism.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • children between 3 years and 12 years 11 months
• • diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale
• • at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11
• • physical development indicative of prepubescence as defined by criteria for Tanner Stage 1
• • if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation
• • have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial
• Exclusion Criteria:
• • presence of known genetic abnormalities associated with ASD (e.g. Fragile X)
• • current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
• • presence of significant medical problems
• • the inability of at least one caregiver to speak and read English to a sufficient level
• • participants taking glutathione agents/prodrugs
• • history of any adverse effects to glutathione agents/prodrugs
• • the inability to drink a sample study compound dissolved in liquid