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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 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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,927 Total Patients Enrolled
University of UtahOTHER
1,139 Previous Clinical Trials
1,697,280 Total Patients Enrolled
Emory UniversityOTHER
1,697 Previous Clinical Trials
2,603,838 Total Patients Enrolled

Media Library

Omega-3 Clinical Trial Eligibility Overview. Trial Name: NCT05774665 — Phase 2
Major Depressive Disorder Research Study Groups: Omega-3, Placebo
Major Depressive Disorder Clinical Trial 2023: Omega-3 Highlights & Side Effects. Trial Name: NCT05774665 — Phase 2
Omega-3 2023 Treatment Timeline for Medical Study. Trial Name: NCT05774665 — Phase 2
~50 spots leftby Jan 2026
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