~30 spots leftby Jan 2026

Omega-3 for Depression

Recruiting in Palo Alto (17 mi)
+2 other locations
MH
Overseen byMark H Rapaport, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Massachusetts General Hospital
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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: Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation? 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: an omega-3 preparation 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.

Research Team

MH

Mark H Rapaport, MD

Principal Investigator

University of Utah

Eligibility Criteria

Adults with obesity and major depressive disorder (MDD) who haven't improved after 2-5 antidepressant treatments can join this trial. They must have a certain level of inflammation, speak English, and not be on conflicting medications or have serious health issues that could affect the study.

Inclusion Criteria

BMI >25 kg/m2 and ≤ 40 kg/m2
I have depression that hasn't improved after 2-5 treatments.
My depression is moderate to severe, without much improvement recently.
See 5 more

Exclusion Criteria

A history of severe sensitivity to soy products, fish products, or PUFA supplements
I started psychotherapy within the last 90 days.
I've been taking over 1g/day of omega-3 supplements for 6 weeks during my current depression episode.
See 18 more

Treatment Details

Interventions

  • Omega 3 (Specialized Pro-resolving Lipid Mediators)
Trial OverviewThe trial is testing if omega-3 fatty acids can boost anti-inflammatory compounds and improve depression symptoms in patients whose antidepressants aren't fully effective. Participants will randomly receive either omega-3 supplements or a placebo for 12 weeks while their inflammation levels and mood are monitored.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omega-3Experimental Treatment1 Intervention
Omega-3 fatty acid (ProEPA Xtra) capsules containing a total of 4 g/day of eicosapentaenoic acid (EPA), administered for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules containing soybean oil (about 54% omega-6 and 6% omega-3, but no EPA or docosahexaenoic acid (DHA)), and matched to the ProEPA Xtra capsules in terms of appearance, odor, and taste.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski profile image

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+
Jeffrey Wilkins profile image

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman profile image

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+
Dr. R. Donald Harvey profile image

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter profile image

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University