At a glance
ClinicalIndex Comparison Record- ✓Age 4 to 12 years
- ✓Diagnosis of autistic disorder, Asperger's disorder, or PDD NOS
- ✓If on psychotropic medications, must be at constant dose for 60 days with no changes planned during trial
- ✓Able to swallow capsules
- ✕Medical conditions that significantly increase risk or hamper assessment (e.g., unstable hypertension, cardiac disease, asthma, kidney disease, seizure disorder)
- ✕Weight <15 kg
- ✕Concurrent glutamatergic agents (e.g., dextromethorphan, D-cycloserine, amantadine, memantine, lamotrigine, riluzole) or antioxidants (high-dose vitamins, DMG, TMG) within 30 days; exception for short-term dextromethorphan cough suppressant if stopped ≥7 days before baseline
- ✕Daily acetaminophen or NSAIDs within 30 days of baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
In Brief
A Phase 2 clinical trial evaluating N-acetylcysteine and Placebo for Autistic Disorder and 2 related conditions. Completed, enrolled 31 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.
Study Details
Timeline
Interventions
Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.
Subjects randomized to placebo arm will receive placebo pill for duration of study.