A Study of Glutathione in Children With Autism Spectrum Disorder

An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder

The aim of this study is to investigate if taking a supplement called Glutathione by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The researchers plan to involve 24 individuals with ASD and give them oral Glutathione for 12 weeks.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: Glutathione

Detailed Description

The goal of the proposed study is to evaluate the safety and feasibility of oral Glutathione in children and adolescents who have Autism Spectrum Disorder. Twenty-four subjects with ASD will receive 12 weeks of oral Glutathione reduced. The hypothesis to be tested is that: Oral Glutathione will be effective in increasing the blood level of Glutathione, which may help to decrease some problem behaviors and irritability in this particular ASD population. The second aim of this study is to evaluate the tolerability of oral Glutathione. The proposed study may provide needed data for future studies aimed at the treatment of aggressive behaviors that can be seen in this patient population.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Boys and girls ages 4-17
• Current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5
• Parents of Children ages 4-17 with a current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5

Exclusion Criteria:

• Unstable medical illness or clinically significant abnormalities on physical examination;
• History of seizures;
• History of Hematological disorders;
• Myocardial infarction within 6 months;
• Current pregnancy or lactation, or inadequate contraception in girls of childbearing potential;
• Current or recent (past 3 months) DSM-5 substance abuse or dependence;
• Illegal substance use within 2 weeks of study initiation;
• Previous treatment with Glutathione;
• Current treatment with N-acetylcysteine, milk thistle, Vitamin C, Vitamin B, Grape Seed Extract, Amino Acids, or Zinc
• Current treatment with Dextromethorphan, D-cycloserine, Amantadine, Memantine, Lamotrigine or Riluzole
• Asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glutathione Oral Supplementation; Glutathione will be the only study medication dispensed to subjects for this study. Subjects will be told to take the first dose of study medication after breakfast each day and the second dose in the evening after dinner. The proposed dose range for Glutathione in this study will be 1000mg-3000mg/day based on the subject's weight.	Drug: Glutathione; Giving supplement orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberrant Child Checklist, Looking at Change in the Subscale of the ABC	The Aberrant Behavior Checklist (ABC) measures psychiatric symptoms and behavioral disturbances in individuals with IDD across five subscales: Irritability (0-45), Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Each subscale score is summed to calculate a total score ranging from 0 to 174. Higher scores indicate worse outcomes, with no specific cutoff values, as the measure is used alongside diagnostic tools like the Autism Diagnostic Observation Schedule (ADOS). The ABC is designed to establish baseline symptoms and monitor changes over time, where a decrease in scores reflects improvement, and an increase indicates worsening symptoms.The Aberrant Behavior Checklist (ABC) consists of five subscales: Irritability (0-45), Lethargy (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Higher scores represent more severe symptoms. The total ABC score ranges from 0 to 174	baseline and 12 weeks. To clarify, all pre-specified Primary and Secondary Outcome Measures were collected at baseline and the 12-week endpoint only. No intermediate assessments were conducted.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Responsiveness Scale	The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item caregiver-rated questionnaire that measures the severity of social impairments associated with autism spectrum disorder (ASD) in children and adolescents (ages 2 years 6 months to 18 years). It assesses five domains: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior, as well as a Total Score. T-scores typically range from approximately 30 to 90+, with scores capped at 90 in cases of severe impairment. Higher T-scores indicate greater severity of social impairment (worse outcome), while lower T-scores indicate fewer social difficulties (better outcome). Clinically Relevant Thresholds T-score ≤ 59: Within normal limits T-score 60-65: Mild range (borderline, subclinical difficulties) T-score 66-75: Moderate range (clinically significant impairment) T-score ≥ 76: Severe range (marked impairment)	We only have the Social Responsiveness Scale measurement at baseline.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impression Scale	The Clinical Global Impression (CGI) is a clinician-rated instrument developed for use in NIMH-sponsored clinical trials to provide a brief global assessment of illness severity, improvement, and therapeutic efficacy. The three commonly reported CGI scales are: CGI-Severity (CGI-S): Rates current illness severity from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). CGI-Improvement (CGI-I): Rates change in clinical status from baseline on a 7-point scale, ranging from 1 (Very much improved) to 7 (Very much worse). CGI-Efficacy Index (CGI-E): Balances therapeutic efficacy with adverse effects, rated on a 4 × 4 grid, where higher scores reflect minimal efficacy and/or significant side effects. Lower CGI-S and CGI-I scores indicate better outcomes (less illness severity and/or greater improvement). Higher CGI-E scores reflect worse outcomes (limited efficacy and/or significant side effects). Higher CGI-E scores reflect worse outcomes	At baseline and the end of the trial (12 weeks)

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Karam Radwan, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Glutathione
• Other Study ID Numbers: IRB19-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Following the completion of the trial and until 2 years from the publication of the trial outcome data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes