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

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04278898

Enrollment

Registered

2020-02-20

Start date

2021-02-12

Completion date

2029-01-31

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Magnetic Resonance Imaging, N-acetylcysteine, Restricted and Repetitive Behaviors, electroencephalography

Brief 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.

Interventions

DRUGN-Acetylcysteine

N-acetylcysteine Single Dose 2700 mg taken orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Inclusion criteria

* children between 3 years and 12 years 11 months at the time of consent * 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.

Design outcomes

Primary

Measure	Time frame
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)	1 hour after single dose

Secondary

Measure	Time frame
Change in Gamma band amplitude and synchronization measured by electroencephalography	1 hour after single dose

Countries

United States

Contacts

CONTACTRamy Chebbo

autismresearch@stanford.edu(650) 723-7845

CONTACTJohn Hegarty, PhD

hegartyj@stanford.edu(650) 723-7845

PRINCIPAL_INVESTIGATORJohn Hegarty, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026