Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach

ClinicalTrials.gov ID: NCT02553915

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Official title

Omega-3 Fatty Acids for MDD With High Inflammation: A Personalized Approach

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This project aims to evaluate whether a dose-response relationship exists between dose of polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in markers of inflammation, and whether these effects differ from placebo. A key secondary aim is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with current major depressive disorder (MDD). To address these aims, the project will use a four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study is to be conducted at two sites: Emory University School of Medicine, and Massachusetts General Hospital. Eligible participants will be between the ages of 18-80 who have current MDD, are overweight, and who demonstrate peripheral inflammation, defined as an high sensitivity C-reactive protein (hs-CRP) level ≥ 3 mg/L. The primary outcome will be change in plasma interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear cells (PBMC) Tumor Necrosis Factor-alpha (TNF-α) expression levels in EPA- versus placebo-treated participants. The results of this investigation are intended to be used to design and power a larger definitive test of the efficacy and biological effects of EPA in patients with major depressive disorder.

Study identification

NCT ID: NCT02553915
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Massachusetts General Hospital; Other
Enrollment: 61 participants

Conditions and interventions

Conditions

Interventions

Other · Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2015 (Actual)
Primary completion: Jul 13, 2018 (Actual)
Completion: Mar 31, 2022 (Actual)
Last update posted: May 2, 2022

2015 – 2022

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Emory University School of Medicine	Atlanta	Georgia	30322	—
Depression Clinical and Research Program at Massachusetts General Hospital	Boston	Massachusetts	02114	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02553915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 2, 2022 · Synced Nov 15, 2026