A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder

• Status: Completed
• Trial end date: 2019-09-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the feasibility of a 9-week, randomized trial of N-acetylcysteine (NAC) compared to placebo in 14 children (age 5 to 12 years) with Autism Spectrum Disorder (ASD) and a moderate level of repetitive self-injurious behavior (SIB). Additional aims are to evaluate the positive predictive value of a screening method to classify children with automatically maintained self-injurious behavior; to evaluate the preliminary efficacy of NAC for reducing repetitive SIB in children with ASD; and to evaluate biomarkers and possible mechanisms of action of NAC in children with ASD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Autism Spectrum Disorder (ASD)

• Confirmed presence of moderate Self Injurious Behavior (SIB)

• Score > 16 on the parent-rated Aberrant Behavior Checklist Irritability subscale (moderate level of disruptive behavior)

• Classified as having automatically maintained SIB (determined during screening by a detailed functional analysis)

Exclusion Criteria:

• On a stable medication dose for less than 4 weeks

• Planned change in medication during the 9-week trial

• Had one or more seizures in the last 6 months