Omega-3 for Depression

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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the impact of omega-3 fatty acids on the production of anti-inflammatory effects and clinical improvement in people with depression who have not responded well to standard antidepressant treatment. The main questions it seeks to answer are: Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation? Is the increase in these anti-inflammatory compounds associated with a stronger antidepressant effect? Participants taking antidepressants that have not worked completely will be assigned at random for a 12-week period to one of the following: an omega-3 preparation an inactive placebo During the course of the study, blood tests will be obtained for compounds associated with inflammation, and questionnaires to measure clinical improvement in depressive symptoms will be administered.

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.

What data supports the effectiveness of the treatment Omega 3 for depression?

Research suggests that omega-3 fatty acids, especially those high in EPA (a type of omega-3), can help reduce symptoms of depression. Studies have shown that adding omega-3 to other depression treatments can improve their effectiveness, and a meta-analysis found that omega-3s with at least 60% EPA are particularly beneficial. ^{1 2 3 4 5}

Is Omega-3 safe for humans?

Omega-3 fatty acids are generally considered safe for humans, with well-established health benefits, especially for heart health. Studies suggest that using Omega-3 as an additional treatment for depression is low risk, although more research is needed to confirm its effectiveness as a primary treatment. ^{2 3 6 7 8}

How does omega-3 treatment for depression differ from other treatments?

Omega-3 treatment for depression is unique because it uses essential fatty acids, like EPA and DHA, which are found in fish and cannot be made by the body. These fatty acids may help improve depression symptoms, especially when EPA is a major component of the supplement, unlike traditional antidepressants that often target brain chemicals directly. ^{1 3 9 10 11}

Research Team

Mark H Rapaport, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of omega-3 PUFAs in depression: A meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinical trials of PUFAs in depression: State of the art. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids on the forced-swimming test. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

ω-3 Fatty acids for major depressive disorder in adults: an abridged Cochrane review. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Omega-3 Polyunsaturated Fatty Acids Supplementation Alleviate Anxiety Rather Than Depressive Symptoms Among First-Diagnosed, Drug-Naïve Major Depressive Disorder Patients: A Randomized Clinical Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids in major depressive disorder. [2009]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Omega-3 Supplementation on Depression in Adults with Cardiometabolic Disease: A Systematic Review of Randomised Control Trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Baseline blood levels of omega-3 and depression remission: a secondary analysis of data from a placebo-controlled trial of omega-3 supplements. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Long-term Supplementation With Marine Omega-3 Fatty Acids vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Omega-3 fatty acids in mood disorders]. [2006]