Omega-3 for Depression

Recruiting in Palo Alto (17 mi)

+2 other locations

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.

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.

+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.

+18 more

Participant Groups

The 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.

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.