Using N-acetylcysteine to reduce repetitive behaviors in children with autism
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial
This study is testing if a nutritional supplement called N-acetylcysteine can help reduce repetitive behaviors in children with autism aged 3 to 12.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05664789 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 12 years with a confirmed diagnosis of autism spectrum disorder and moderate severity of restricted and repetitive behaviors.
Not a fit: Patients with severe symptoms or those who do not meet the eligibility criteria, such as those with significant comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, well-tolerated treatment option for reducing repetitive behaviors in children with autism.
How similar studies have performed: Previous small-scale trials have shown promise for NAC in reducing symptoms of autism, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Department of Psychiatry and Behavioral Sciences — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: John Hegarty, PhD — Stanford University
- Study coordinator: Brianna Alconcher
- Email: autismresearch@stanford.edu
- Phone: (650)723-7845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.