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Clinical Trials/NCT04278898
NCT04278898RecruitingPhase 2

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

Stanford University2 sites in 1 country24 target enrollmentStarted: February 12, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
24
Locations
2
Primary Endpoint
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
3 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

N-acetylcysteine then Placebo

Experimental

Intervention: N-Acetylcysteine (Drug)

Placebo then N-acetylcysteine

Experimental

Intervention: N-Acetylcysteine (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 1 hour after single dose

Secondary Outcomes

  • Change in Gamma band amplitude and synchronization measured by electroencephalography(1 hour after single dose)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Patrick Hegarty

Instructor

Stanford University

Study Sites (2)

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