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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |