NCT03911414

A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (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 (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.

Conditions

• Mood Disturbance
• Mood Disorders
• Natural Supplements
• Alternative Treatment

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 N-acetylcysteine

Timeline

• Start date: 2019-06-18
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2019-04-11
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study