NCT03757585

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

An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-verbal Learning Disorder
• Autism Spectrum Disorder
• Autism

Interventions

Type	Name	Description
DRUG	Open-label Treatment with Omega-3 Fatty Acids + Inositol	Open-label Treatment with Omega-3 Fatty Acids + Inositol
DRUG	Open-label Treatment with N-acetylcysteine	Open-label Treatment with acetylcysteine

Timeline

• Start date: 2019-05-20
• Primary completion: 2024-05-06
• Completion: 2024-05-06
• First posted: 2018-11-29
• Last updated: 2025-06-05
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study