Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
Trial ID or NCT#
NCT04278898
Status
RECRUITING
Purpose
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.
Official Title
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study
Eligibility Criteria
Ages Eligible for Study: 3 Years to 12 Years
Sexes Eligible for Study: 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.
Investigator(s)
John P. Hegarty II
Contact us to find out if this trial is right for you.
Contact
John Hegarty, PhD
650-736-1235
View on ClinicalTrials.gov
