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NCT Number: NCT04278898

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine Single Dose 2700 mg taken orally

Primary outcomes

  1. Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)

    Time frame: 1 hour after single dose

Secondary outcomes

  1. Change in Gamma band amplitude and synchronization measured by electroencephalography

    Time frame: 1 hour after single dose

Study contacts

Contact information is provided by the study sponsor or research team.

John Hegarty, PhD

CONTACT

[email protected]

(650) 723-7845

Ramy Chebbo

CONTACT

[email protected]

(650) 723-7845

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Feb 20, 2020
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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