drugset / Trial / NCT03757585

Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

NCT03757585

RandomizedParallel-groupOpen-labelTreatment

Summary

This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.

Timeline

Start
2019-05-20
Primary completion
2024-05-06
Completion
2024-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Inositol Small molecule 1000 mg
Subject Inositol Small molecule 2000 mg
Subject N-acetylcysteine Small molecule 1800 mg
Subject N-acetylcysteine Small molecule 2400 mg
Subject N-acetylcysteine Small molecule 2700 mg
Subject Omega-3 fatty acids Unknown 1020 mg