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

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.

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

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Drug: N-Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine then Placebo<br> | Drug: N-Acetylcysteine<br>* N-acetylcysteine Single Dose 2700 mg taken orally<br>|
| Experimental: Placebo then N-acetylcysteine<br> | Drug: N-Acetylcysteine<br>* N-acetylcysteine Single Dose 2700 mg taken orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) |  | 1 hour after single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gamma band amplitude and synchronization measured by electroencephalography |  | 1 hour after single dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, N-acetylcysteine, Restricted and Repetitive Behaviors, electroencephalography