A Study of Glutathione in Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05954052
• Other study ID #: IRB19-0017
• Status: Terminated
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Glutathione
Giving supplement orally

Locations

Country	Name	City	State
United States	The University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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)
Secondary	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)