Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.