N-acetylcysteine for Autism
Trial Summary
What is the purpose of this trial?
This trial is testing a nutritional supplement called N-acetylcysteine (NAC) to help children with autism spectrum disorder. NAC has shown promise in smaller studies for reducing repetitive behaviors. The study aims to understand how NAC works and its effects on these behaviors. NAC has been studied for its potential to reduce irritability and self-injurious behaviors in children with autism spectrum disorder (ASD).
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial requires that you have been on a stable medication regimen for at least 30 days and that there are no expected changes during the trial.
What data supports the effectiveness of the drug N-acetylcysteine for autism?
Research suggests that N-acetylcysteine (NAC) may help reduce irritability and aggressive behaviors in children and adolescents with autism. In one case, a child's social interaction improved and aggressive behaviors decreased after taking NAC, indicating potential benefits for some autism symptoms.12345
Is N-acetylcysteine (NAC) generally safe for human use?
N-acetylcysteine (NAC) is generally considered safe for human use and has been used for various medical purposes, including as a treatment for acetaminophen overdose and as a mucolytic agent (helps break down mucus). It is important to follow medical advice and dosage recommendations to minimize any potential side effects.678910
How is the drug N-acetylcysteine unique for treating autism?
N-acetylcysteine (NAC) is unique for treating autism because it acts as an antioxidant, potentially reducing oxidative stress and neuroinflammation, which are believed to contribute to autism. Unlike other treatments, NAC may improve social interaction and decrease irritability and aggressive behaviors in individuals with autism.134511
Research Team
John Hegarty, PhD
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for children aged 3 to under 13 with autism spectrum disorder, confirmed by specific diagnostic tools. They must be prepubescent, medically stable, and have no metal in their body that would interfere with MRI or EEG tests. Participants should be on a steady medication and treatment plan for at least 30 days before the trial starts and not expected to change during the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive N-acetylcysteine (NAC) to target restricted and repetitive behaviors in children with autism
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue receiving NAC to further assess long-term effects
Treatment Details
Interventions
- N-acetylcysteine
N-acetylcysteine is already approved in United States, European Union for the following indications:
- Acetaminophen overdose
- Chronic bronchitis
- Cystic fibrosis
- Mucolytic agent
- Paracetamol overdose
- Chronic bronchitis
- Cystic fibrosis
- Mucolytic agent
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator