NCT04278898RecruitingPhase 2
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Stanford University
- 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
John Patrick Hegarty
Instructor
Stanford University
Study Sites (2)
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