A Study of Glutathione in Children With Autism Spectrum Disorder

Phase 4

Terminated

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: Glutathione

• Registration Number: NCT05954052
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Status Verified: 2023-08
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glutathione Oral Supplementation	Glutathione	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 Outcome Measures

Name	Time	Method
Aberrant Child Checklist, looking at change in the subscale of the ABC	This will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)	The Aberrant Behavior Checklist (ABC) is a scale designed to measure psychiatric symptoms and behavioral disturbance exhibited by individuals with IDD across 5 domains: Irritability, Agitation, \& Crying; Lethargy/Social Withdrawal; Stereotypic Behavior; Hyperactivity/Noncompliance. he subscales and the respective number of items are as follows: (a) Irritability (15 items), (b) Social Withdrawal (16 items), (c) Stereotypic Behavior (7 items), (d) Hyperactivity/Noncompliance (16 items), and (e) Inappropriate Speech (4 items). The score is intended to check baseline and monitor changes. There is no cutoff as the study relied on diagnosis based on Autism Diagnostic Observation Schedule ADOS. Change is being assessed including monitoring for any worsening of symptoms reported in the subscales.

Secondary Outcome Measures

Name	Time	Method
Change in Vineland Adaptive Behavior Scales	At baseline and end of the trial (12 weeks)	Questionnaire is assessment of individuals with intellectual, developmental (including autism), and other disabilities. Domains assessed include communication, daily living skills, socialization, motor skills, and maladaptive behaviors.
Change in Social responsiveness Scale	At baseline and end of the trial (12 weeks)	The SRS-2 identifies social impairment associated with ASD and quantifies its severity. Sensitive enough to detect even subtle symptoms but specific enough to differentiate clinical groups. the SRS-2 identifies social impairment associated with autism spectrum disorders (ASDs) and quantifies its severity. It's sensitive enough to detect even subtle symptoms, yet specific enough to differentiate clinical groups, both within the autism spectrum and between ASD and other disorders. The study would not require a specific score.

Trial Locations

Locations (1)

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States