Trial · Interventional

TerminatedPhase 4Results postedRegistry data

A Study of Glutathione in Children With Autism Spectrum Disorder

NCTNCT05954052Other idIRB19-0017

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: lack of funding and difficulty with phlebotomy in children with Autism

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 6 participants (actual)
Sponsor: University of Chicago · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 1 Jul 2019
Primary completion: 15 Aug 2023
Completion: 15 Aug 2023
First posted: 20 Jul 2023
Last update posted: 18 Sept 2025
Conditions: Autism Spectrum Disorder

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021202220232024

Ph 4
A Study of Glutathione in Children With Autism Spectrum Disorder
NCT05954052
1 Jul 2019 to 15 Aug 2023
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GlutathioneDrug

Arms1

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Aberrant Child Checklist, Looking at Change in the Subscale of the ABC
Time frame · 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.
Registry description
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

Secondary outcomes(1)

Social Responsiveness Scale
Time frame · We only have the Social Responsiveness Scale measurement at baseline.
Registry description
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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.

Aberrant Child Checklist, Looking at Change in the Subscale of the ABC

Group	Value (units on a scale)
Glutathione	18.60

Secondary and other outcome results(5)

Secondary outcomeMedian· We only have the Social Responsiveness Scale measurement at baseline.

Social Responsiveness Scale

Group	Value (T-score for this instrument.)
Glutathione Oral Supplementation	75.5

Other pre specified outcomeMedian· At baseline and the end of the trial (12 weeks)

Change in Clinical Global Impression Scale

Group	Value (score on a scale)
Glutathione Oral Supplementation	4

Post hoc outcome· 12 weeks

Clinical Global Impression - Severity Scale (CGI-S) Range for Participants

Group	Value

Post hoc outcome· 12 weeks

Clinical Global Impression - Improvement Scale: Rates Change in Clinical Status From Baseline on a 7-point Scale, Ranging From 1 (Very Much Improved) to 7 (Very Much Worse).

Group	Value

Post hoc outcome· 12 weeks

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.

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GlutathioneWe have one arm who took supplement	0 / 6	1 / 6	1 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 4 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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