Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
- Registration Number
- NCT04278898
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo then N-acetylcysteine N-Acetylcysteine - N-acetylcysteine then Placebo N-Acetylcysteine -
- Primary Outcome Measures
Name Time Method Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) 1 hour after single dose
- Secondary Outcome Measures
Name Time Method Change in Gamma band amplitude and synchronization measured by electroencephalography 1 hour after single dose
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States