Clinical trial NCT05954052: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Keywords: Autism
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Aberrant Child Checklist, looking at change in the subscale of the ABC
timeFrame: This will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)
Secondary outcomes:
measure: Change in Social responsiveness Scale
timeFrame: At baseline and end of the trial (12 weeks)
measure: Change in Vineland Adaptive Behavior Scales
timeFrame: At baseline and end of the trial (12 weeks)
Other outcomes:
measure: Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)
timeFrame: At a baseline and end of the trial (12 weeks)
measure: Change in Clinical Global Impression Scale
timeFrame: At baseline and the end of the trial (12 weeks)
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Karam Radwan, MD
role: PRINCIPAL_INVESTIGATOR
References: