2.1. Study Design
aggression, irritability, DSM-5
This 12-week open-label pilot study was conducted to investigate the efficacy of glutathione use as a supplement for the symptomatic treatment of irritability and aggression in children with ASD, as defined by criteria set forth in the DSM-5. Trials were conducted in the outpatient setting at the University of Chicago. Institutional review board proposal was submitted and approved for the intent and purpose of this experimental study. The study is registered under NCT05954052 with clincialtrials.gov. All studied subjects agree to this voluntary study without financial incentives or otherwise. After obtaining informed consent from parents, subjects are screened for inclusion and exclusion criteria as highlighted below. For the purpose of this study, oral glutathione refers to oral supplementation with Opitac