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

Summary

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.

Conditions

• Major Depressive Disorder
• Overweight
• Inflammation

Interventions

OTHER

Placebo

Soybean oil placebo

DRUG

EPA 1 g/day

Omega-3 fatty acid extracted from fish oil, 1 g/day

DRUG

EPA 2 g/day

Omega-3 fatty acid extracted from fish oil, 2 g/day

DRUG

EPA 4 g/day

Omega-3 fatty acid extracted from fish oil, 4 g/day

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Maurizio Fava, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-07-13

Completion

2022-03-31

Countries

• United States

Study Locations