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Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression

NCT05774665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the impact of omega-3 fatty acids on the production of anti-inflammatory effects and clinical improvement in people with depression who have not responded well to standard antidepressant treatment. The main questions it seeks to answer are:

1. Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation?
2. Is the increase in these anti-inflammatory compounds associated with a stronger antidepressant effect?

Participants taking antidepressants that have not worked completely will be assigned at random for a 12-week period to one of the following:

1. an omega-3 preparation
2. an inactive placebo

During the course of the study, blood tests will be obtained for compounds associated with inflammation, and questionnaires to measure clinical improvement in depressive symptoms will be administered.

Conditions

Interventions

DRUG

Omega 3

Omega-3 fatty acid enriched for eicosapentaenoic acid (EPA)

OTHER

Placebo

Placebo consisting of soybean oil (about 54% omega-6 and 6% omega-3, but no EPA or docosahexaenoic acid (DHA)).

Sponsors & Collaborators

Principal Investigators

  • Mark H Rapaport, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774665 on ClinicalTrials.gov