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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05664789
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • N acetyl cysteine — DRUG
    N-acetylcysteine (NAC) is an over-the-counter dietary supplement that is relatively well tolerated and exhibits minimal side effects, even at high dosages. N
  • Placebo — DRUG
    matched placebo

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: N-acetylcysteine
    12 week administration of active study compound
  • Placebo Comparator: Placebo
    12 week administration of matched placebo

Primary Outcome Measure

Change in Children's Yale Brown-Obsessive Compulsive Scale for Autism Spectrum Disorder (CYBOCS-ASD) at 12 weeks [ Time Frame: Screening and week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry and Behavioral SciencesPalo AltoCalifornia94304
Ramy Chebbo
[email protected]
(650)723-7845

Find similar trials in Palo Alto, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Department of Psychiatry and Behavioral Sciences· Palo Alto, CA

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