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Omega-3 for Depression

Phase 2

Waitlist Available

Led By Mark H Rapaport, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18 to 65 years

Are currently experiencing depression

Must not have

Have a diagnosis of psychotic disorder, bipolar disorder, obsessive compulsive disorder, bulimia nervosa, or anorexia nervosa

Timeline

Screening 3 weeks

Treatment 12 weeks

Follow Up 12 weeks

Summary

This trial will assess if adding omega-3 fatty acids to antidepressant treatment can reduce inflammation and improve depression symptoms in people who haven't responded to standard treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from omega-3 supplements may include fishy aftertaste, upset stomach, loose stools, and possible interactions with other medications. However, specific side effects related to this trial are not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks1 visit

Treatment ~ 12 weeks8 visits

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ 12 weeks

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, 12 weeks for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18-HEPE (18-hydroxy eicosapentaeoic acid) Change

Secondary study objectives

18-HEPE (18-hydroxy eicosapentaeoic acid) Change in Treatment Responders

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omega 3

2019

Completed Phase 4

~1560

0 / 5Eligibility criteria met