RECRUITING

Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial

Conditions

Autism Spectrum Disorder Magnetic resonance imaging N-acetyl cysteine Restricted and repetitive behaviors Electroencephalography

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC.

Official Title

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial

Quick Facts

Study Start:2023-04-26

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05664789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* children between 3 years and 12 years 11 months * diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale * at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11 * physical development indicative of prepubescence as defined by criteria for Tanner Stage 1 * if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation * have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial	* presence of known genetic abnormalities associated with ASD (e.g. Fragile X) * current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia) * presence of significant medical problems * the inability of at least one caregiver to speak and read English to a sufficient level * participants taking glutathione agents/prodrugs * history of any adverse effects to glutathione agents/prodrugs * the inability to drink a sample study compound dissolved in liquid

Inclusion Criteria

Exclusion Criteria

* children between 3 years and 12 years 11 months
* diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale
* at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11
* physical development indicative of prepubescence as defined by criteria for Tanner Stage 1
* if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation
* have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial

* presence of known genetic abnormalities associated with ASD (e.g. Fragile X)
* current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)
* presence of significant medical problems
* the inability of at least one caregiver to speak and read English to a sufficient level
* participants taking glutathione agents/prodrugs
* history of any adverse effects to glutathione agents/prodrugs
* the inability to drink a sample study compound dissolved in liquid

Contacts and Locations

Study Contact

Brianna Alconcher

CONTACT

(650)723-7845

autismresearch@stanford.edu

John Hegarty, PhD

CONTACT

(650)723-7845

autismresearch@stanford.edu

Principal Investigator

John Hegarty, PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Department of Psychiatry and Behavioral Sciences

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

John Hegarty, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-26

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-04-26

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Magnetic resonance imaging
N-acetyl cysteine
Restricted and repetitive behaviors
Electroencephalography

Additional Relevant MeSH Terms

Autism Spectrum Disorder