Clinical trial Recruiting at 1 site Interventional Ages 13 to 18

Omega-3 for inflammation and the gut microbiome in young people with depression

Official title: Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial

Run by China Medical University Hospital · NCT07363551 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages13 Years to 18 Years
SexAll
Enrollment60 (estimated)
SponsorChina Medical University Hospital
Academic / other
Locations1 site (Taichung, Taichung)
StatusRecruiting
StartedJune 9, 2021
Main results expectedMay 31, 2026
Study endsMay 31, 2026
Registry record updatedJanuary 26, 2026
Trial IDNCT07363551 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • China Medical University
    Taichung, Taichung, Taiwan
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.