Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Magnetic Resonance Imaging, N-acetylcysteine, Restricted and Repetitive Behaviors, Electroencephalography Read More

Inclusion Criteria:

• Inclusion criteria: successful completion of IRB protocols 54931 or 65821.

Inclusion for 54931 include:

• children between 3 years and 12 years 11 months
• diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale
• at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale in ASD score ≥ 11
• physical development indicative of prepubescence as defined by criteria for Tanner Stage 1
• medically stable
• passes MR safety screening (e.g., no metal in the body).

Inclusion for 65821:

• same criteria as above for 54931
• have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial
• successfully completes baseline neuroimaging (MRI or EEG).

Exclusion Criteria:

• significant adverse affects that led to withdrawal or early termination from IRB 54931 or 65821.

Exclusion criteria for 54931 and 65821 include:

• presence of known genetic abnormalities associated with ASD (e.g. Fragile X)
• current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
• presence of significant medical problems
• the inability of at least one caregiver to speak and read English to a sufficient level, • • participants taking glutathione agents/prodrugs, or (6) the inability to drink a dissolved agent.