Omega-3 for Depression

Not yet recruiting at 2 trial locations

Overseen By David Mischoulon, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: Antidepressants

Must not be taking: Antipsychotics, Lithium, NSAIDs

Disqualifiers: Psychotic disorder, Bipolar, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omega-3 fatty acids can reduce inflammation and improve symptoms in people with depression, particularly those whose current antidepressants are ineffective. Participants will receive either omega-3 capsules or a placebo (a pill with no active ingredient), and researchers will track their progress through blood tests and questionnaires. Individuals with depression that hasn't improved despite trying different antidepressants might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You can continue taking your current antidepressant, but you must stop using any other psychotropic medications (except for certain allowed ones) at least 2 weeks before the study starts. You also need to avoid certain medications like NSAIDs, oral steroids, and others that might affect the study results.

Is there any evidence suggesting that omega-3 fatty acids are likely to be safe for humans?

Research has shown that omega-3 fatty acids are generally safe. Studies have found that omega-3 can help treat depression, especially when inflammation is involved. A type of omega-3 used in research, which includes eicosapentaenoic acid (EPA), was well-tolerated by participants.

Most people taking omega-3 do not experience serious side effects. Some might notice mild issues like a fishy taste, an upset stomach, or loose stools, which usually resolve quickly.

In this trial, participants will take a higher dose of omega-3 (4 grams per day) than typically recommended, but it remains considered safe. Evidence suggests this is unlikely to cause harm, though monitoring for any unusual symptoms is important. Always consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for depression, such as SSRIs and SNRIs, work by altering neurotransmitter levels in the brain. However, Omega-3 is unique because it uses eicosapentaenoic acid (EPA), an omega-3 fatty acid, which may reduce inflammation and improve brain function. Unlike traditional antidepressants that can have various side effects, Omega-3 is a natural supplement that could offer a more tolerable option for patients. Researchers are excited about its potential to provide a safer and possibly more effective alternative to current depression therapies.

What evidence suggests that omega-3 might be an effective treatment for depression?

Research has shown that omega-3 fatty acids, particularly those high in EPA (a type of omega-3), can aid in alleviating depression. Studies have found that omega-3s can reduce tiredness and improve sleep in individuals with depression. Some research also suggests that higher doses of omega-3 can enhance motivation and cognitive function in those who are depressed. Omega-3s may help by reducing inflammation, which is believed to be linked to depression. Overall, promising evidence suggests that omega-3s could be a valuable addition to depression treatment. Participants in this trial will receive either omega-3 fatty acid capsules or placebo capsules to evaluate their effectiveness in treating depression. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark H Rapaport, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 4 g/day of EPA-enriched omega-3 or placebo for 12 weeks

12 weeks

Regular visits for blood tests and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omega 3

Trial Overview 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.

How Is the Trial Designed?

Group I: Omega-3 Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6683166/

Efficacy of omega-3 PUFAs in depression: A meta-analysis Current evidence supports the finding that omega-3 PUFAs with EPA ≥ 60% at a dosage of ≤1 g/d would have beneficial effects on depression.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31383846/

Efficacy of omega-3 PUFAs in depression: A meta-analysis Current evidence supports the finding that omega-3 PUFAs with EPA ≥ 60% at a dosage of ≤1 g/d would have beneficial effects on depression.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0889159124002733

Omega-3 fatty acids for inflamed depression – A match ... In this match-mismatch study n-3 fatty acids were effective in inflamed depression. N-3 fatty acids also improved symptoms of fatigue and sleeping difficulties.

4. mghpsychnews.org mghpsychnews.org/omega-3-fatty-acids-improve-depression-motivation-and-cognition/

High-Dose Omega-3 Fatty Acids Improve Aspects of ... This exploratory clinical trial indicates that higher doses of omega-3 fatty acids improves motivational symptoms and cognition in depressed individuals.

5. health.harvard.edu health.harvard.edu/blog/omega-3-fatty-acids-for-mood-disorders-2018080314414

Omega-3 fatty acids for mood disorders While DHA is thought to be less effective as an antidepressant, it may have protective effects against suicide. Recent work at Massachusetts ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5481805/

Omega-3 fatty acids and the treatment of depression There are number of studies which shows that omega-3 fatty acids are proving to be very effective against the treatment of major depression disorder and other ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.

8. nature.com nature.com/articles/s41398-019-0515-5

Efficacy of omega-3 PUFAs in depression: A meta-analysis Current evidence supports the finding that omega-3 PUFAs with EPA ≥ 60% at a dosage of ≤1 g/d would have beneficial effects on depression.