CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Omega 3 Fatty Acids +1 moredrug
Likely dose
Omega 3 Fatty Acids 1.2gfrom 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/NCT00962598
NCT00962598Phase 2Completed
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The Role Of Omega-3 Fatty Acids In Adolescent Depression

Icahn School of Medicine at Mount Sinai·interventional·Posted Aug 20, 2009·Updated Apr 24, 2018

In Brief

A Phase 2 clinical trial evaluating Omega 3 Fatty Acids and Corn oil for Depressive Disorder, Major. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton magnetic resonance imaging.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 20, 2009
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 16.9 years ago

Interventions

Omega 3 Fatty Acidsdrug

The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.

Corn oildietary

The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.