CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 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/NCT03757585
NCT03757585Phase 4Completed

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)

Massachusetts General Hospital·interventional·Posted Nov 29, 2018·Updated Jun 5, 2025

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 Non-verbal Learning Disorder and 2 related conditions. Completed, enrolled 54 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 29, 2018
Enrollment StartMay 20, 2019
Primary CompletionMay 6, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.6 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 acetylcysteine