Omega-3 for inflammation and the gut microbiome in young people with depression
Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial
This 12-week double-blind randomized test will see if omega-3 supplements help symptoms, reduce inflammation, and change gut bacteria in young people with major depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, Taichung) |
| Trial ID | NCT07363551 on ClinicalTrials.gov |
What this trial studies
This 12-week double-blind randomized controlled trial compares omega-3 fatty acid supplements with placebo in youths diagnosed with a DSM-5 major depressive episode. Participants will be randomized and followed with clinical symptom ratings, blood tests for inflammatory biomarkers, and stool sampling for gut microbiota profiling. The protocol excludes those with a recent change in antidepressant medication or psychotherapy within four weeks and anyone allergic to omega-3. The single-center trial is conducted at China Medical University Hospital in Taichung, Taiwan.
Who should consider this trial
Good fit: Young people with a DSM-5 diagnosis of a current major depressive episode who have had no change in antidepressant medication or psychotherapy in the prior four weeks and are not allergic to omega-3 are ideal candidates.
Not a fit: Patients who recently changed antidepressant or psychotherapy treatment, are allergic to omega-3, or whose primary diagnosis is not a major depressive episode are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, omega-3 supplementation could reduce depressive symptoms and lower inflammation while favorably shifting gut microbiota in young people.
How similar studies have performed: Prior trials and meta-analyses have reported modest antidepressant benefits for omega-3 (especially EPA-rich formulations), while effects on inflammatory markers and gut microbiota remain less consistently demonstrated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Youth with a DSM-5 diagnosis of MDE Exclusion Criteria: * Has a recent change in antidepressants or psychotherapy treatment within 4 weeks. * Allergic to omega-3 fatty acids
Where this trial is running
Taichung, Taichung
- China Medical University — Taichung, Taichung, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.