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) 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.	This will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social responsiveness Scale	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.	At baseline and end of the trial (12 weeks)
Change in Vineland Adaptive Behavior Scales	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.	At baseline and end of the trial (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)	The PRAS-ASD is a reliable and valid measure that can be used to assess severity of anxiety in youth with ASD and evaluate change with treatment. It is a 25-item Parent-Rated Anxiety Scale for ASD (PRAS-ASD) designed to measure anxiety symptoms in children with ASD.	At a baseline and end of the trial (12 weeks)
Change in Clinical Global Impression Scale	The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. CGI-C scores range from 1 (very much improved) through to 7 (very much worse).	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 (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• 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