Back to resultsA Study of Glutathione in Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glutathione
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorder focused on measuring Autism
Eligibility Criteria
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
Sites / Locations
- The University of Chicago Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glutathione Oral Supplementation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05954052
Brief Title
A Study of Glutathione in Children With Autism Spectrum Disorder
Official Title
An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of funding and difficulty with phlebotomy in children with Autism
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutathione Oral Supplementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glutathione
Intervention Description
Giving supplement orally
Primary Outcome Measure Information:
Title
Aberrant Child Checklist, looking at change in the subscale of the ABC
Description
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.
Time Frame
This will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)
Secondary Outcome Measure Information:
Title
Change in Social responsiveness Scale
Description
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.
Time Frame
At baseline and end of the trial (12 weeks)
Title
Change in Vineland Adaptive Behavior Scales
Description
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.
Time Frame
At baseline and end of the trial (12 weeks)
Other Pre-specified Outcome Measures:
Title
Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)
Description
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.
Time Frame
At a baseline and end of the trial (12 weeks)
Title
Change in Clinical Global Impression Scale
Description
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).
Time Frame
At baseline and the end of the trial (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karam Radwan, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Following the completion of the trial and until 2 years from the publication of the trial outcome data.
Learn more about this trial
A Study of Glutathione in Children With Autism Spectrum Disorder
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