CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Open-label Treatment with Omega-3 Fatty Acids + Inositol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03911414
NCT03911414Phase 4Completed
CompareCT.gov

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

Massachusetts General Hospital·interventional·Posted Apr 11, 2019·Updated Mar 18, 2026

In Brief

A Phase 4 clinical trial evaluating Open-label Treatment with Omega-3 Fatty Acids + Inositol and Open-label Treatment with N-acetylcysteine for Mood Disturbance and 3 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMood Disturbance, Mood Disorders, Natural Supplements, Alternative Treatment
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 11, 2019
Enrollment StartJun 18, 2019
Primary CompletionDec 4, 2024
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 7.2 years ago

Interventions

Open-label Treatment with Omega-3 Fatty Acids + Inositoldrug

Open-label Treatment with Omega-3 Fatty Acids + Inositol

Open-label Treatment with N-acetylcysteinedrug

Open-label Treatment with N-acetylcysteine