NCT05664789RecruitingPhase 2/3
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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 and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 26 Apr 2023
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Stanford University
- Diseases
- Autism
- NCT number
- NCT05664789
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 144
- From 26 Apr 2023 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
- history of any adverse effects to glutathione agents/prodrugs
Other
- presence of known genetic abnormalities associated with ASD (e.g. Fragile X)
- 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
- the inability to drink a sample study compound dissolved in liquid
Who the study is looking for
- 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
Age in the registry: 3 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry and Behavioral Sciences Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.