A Study of Glutathione in Children With Autism Spectrum Disorder

NCT05954052 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB19-0017
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Social Responsiveness Scale

  We only have the Social Responsiveness Scale measurement at baseline.

Other Outcomes (1)

• Change in Clinical Global Impression Scale

  At baseline and the end of the trial (12 weeks)

Study Arms (1)

Glutathione Oral Supplementation

EXPERIMENTAL

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

Interventions

Glutathione DRUG

Giving supplement orally

Glutathione Oral Supplementation

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination due to lack of funding and difficulty with phlebotomy in children with Autism

Results Point of Contact

• Title: Karam Radwan, MD
• Organization: University of Chicago

radwan@uchicago.edu

7738346686

Study Officials

• Karam Radwan, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: July 20, 2023
• Study Start: July 1, 2019
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following the completion of the trial and until 2 years from the publication of the trial outcome data.

Locations

US (1)