Using N-acetylcysteine to reduce repetitive behaviors in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the effects of N-acetylcysteine (NAC), a nutritional supplement, on reducing restricted and repetitive behaviors in children diagnosed with autism spectrum disorder. The study will be a 12-week double-blind, randomized, placebo-controlled trial, assessing the neurobiological mechanisms of NAC through neuroimaging techniques such as MRI and EEG. Participants will include children aged 3 to 12 years with confirmed autism diagnoses and moderate severity of symptoms. The trial seeks to provide insights into the clinical benefits of NAC and its potential role in managing autism-related behaviors.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Psychiatry and Behavioral Sciences
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: John Hegarty, PhD — Stanford University
• Study coordinator: Ramy Chebbo
• Email: autismresearch@stanford.edu
• Phone: (650)723-7845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.