MedTrace Logo

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

NCT03911414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-03-18

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet Wozniak, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2024-12-04
Completion
2024-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911414 on ClinicalTrials.gov