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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
18-HEPE (18-hydroxy eicosapentaeoic acid) Change
Secondary outcome measures
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
~1530

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,869 Total Patients Enrolled
71 Trials studying Obesity
291,094 Patients Enrolled for Obesity
University of UtahOTHER
1,104 Previous Clinical Trials
1,782,453 Total Patients Enrolled
16 Trials studying Obesity
2,400 Patients Enrolled for Obesity
Emory UniversityOTHER
1,645 Previous Clinical Trials
2,564,470 Total Patients Enrolled
22 Trials studying Obesity
15,722 Patients Enrolled for Obesity

Media Library

Omega-3 Clinical Trial Eligibility Overview. Trial Name: NCT05774665 — Phase 2
Obesity Research Study Groups: Omega-3, Placebo
Obesity 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
~53 spots leftby Jan 2026
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