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NCT Number: NCT07363551

Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression

This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Pei-Chen Chang, MD

PRINCIPAL_INVESTIGATOR

Pei-Chen Chang, MD, Master

CONTACT

[email protected]

886 4 22052121

About this study

This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder. Outcome measures including clinical symptoms, inflammation biomarkers and gut microbiota profiles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids

Combination Product

omega-3 fatty acids (EPA)

Placebo

Dietary Supplement

soy bean oil

Primary outcomes

  1. clinical symptoms

    Time frame: week 0,1,2,4,8,12

    Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level

    • 0-7: No depression / Normal
    • 8-13: Mild depression
    • 14-18: Moderate depression
    • 19-22: Severe depression -≥23: Very severe depression

Secondary outcomes

  1. gut microbiota

    Time frame: week 0,12

    gut microbiota

  2. inflammatory cytokines (IL-6, hsCRP)

    Time frame: week 0,12

    blood inflammatory cytokines

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Acronym: OMIMYDep

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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