NCT03143075

Do Omega-3 Fatty Acids Have an Antidepressant Effect in Patients With Signs of Peripheral Inflammation?

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day in Major Depressive Disorder in 95 participants. Completed in 9 May 2023.

Timeline

1 August 2017

Primary endpoint
9 May 2023

9 May 2023

Quick facts

Lead sponsor	Region Skane
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	95
Start date	1 August 2017
Primary completion	9 May 2023
Estimated completion	9 May 2023
Sites	1 location across Sweden

Drugs / interventions tested

• Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Region Skane — full company profile →

Who can join

Adults 18 to 80, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, the investigators will stratify depressed subjects a priori based on CRP levels to test the hypothesis that eicosapentaenoic (EPA) would be more efficacious to treat depression in subjects with high CRP levels compared to subjects with low CRP levels.

Depressed subjects, with ongoing stabilized antidepressive treatment who remain clinically depressed, will be enrolled in an "Inflammation group" or in a "Non-inflammation group" depending on baseline levels of CRP. Subjects in both groups will receive EPA enriched omega-3 fatty acids for 8 weeks, added to their pre-stabilized antidepressant medication.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of eicosapentaenoic acid in inflammatory depression: study protocol for a match-mismatch trial.
   Suneson K, Ängeby F, Lindahl J, Söderberg G, et al · · 2022 · cited 7× · PMID 36536364 · DOI 10.1186/s12888-022-04430-z
2. Systemic Inflammation at the Crossroad of Major Depressive Disorder and Comorbidities: A Narrative Review.
   Vitali E, Cattane N, D'Aprile I, Petrillo G, et al · · 2025 · cited 2× · PMID 41096651 · DOI 10.3390/ijms26199382
3. Kynurenine pathway metabolites are increased in inflammatory depression and decrease with omega-3 treatment.
   Lindahl J, Söderberg Veibäck G, Suneson K, Blanking W, et al · · 2026 · PMID 41969822 · DOI 10.1016/j.bbih.2026.101221