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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
17-item Hamilton Depression Rating Scale (HAM-D) score ≥15, and <25% decrease in score between screen and baseline
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.

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.
Select...
My depression is moderate to severe, without much improvement recently.

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
2,918 Previous Clinical Trials
13,192,755 Total Patients Enrolled
71 Trials studying Obesity
290,891 Patients Enrolled for Obesity
University of UtahOTHER
1,088 Previous Clinical Trials
1,728,269 Total Patients Enrolled
16 Trials studying Obesity
2,400 Patients Enrolled for Obesity
Emory UniversityOTHER
1,627 Previous Clinical Trials
2,560,685 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accommodating for senior citizens?

"This clinical trial is for individuals aged 18 to 85. However, there are 274 trials specifically designed for people who fall under the age of majority and 1469 studies dedicated to those over 65 years old."

Answered by AI

Does this clinical research have any open positions?

"The posted clinical trial is not presently recruiting any participants, as indicated from its latest update on the 16th of March 2023. Nevertheless, there are 2013 other medical studies available that are currently enrolling patients."

Answered by AI

Has Omega-3 received authorization from the US Food & Drug Administration?

"Although there is limited evidence of Omega-3's efficacy, clinical data has confirmed its safety and thus it earned a score of 2."

Answered by AI

Would I pass the criteria to participate in this trial?

"For admittance into this research, potential participants must have evidence of inflammation and fall in the age range between 18 to 85. This clinical trial aims to receive about 90 test subjects."

Answered by AI

Who else is applying?

What site did they apply to?
Depression Clinical and Research Program at Massachusetts General Hospital
Emory University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~53 spots leftby Jan 2026