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

January 22, 2026 updated by: Pei-Chen Chang, China Medical University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung
      • Taichung, Taichung, Taiwan, 404
        • Recruiting
        • China Medical University
        • Contact:
        • Principal Investigator:
          • Pei-Chen Chang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: omega-3
EPA
Combination product: Omega-3 fatty acids
omega-3 fatty acids (EPA)
Placebo Comparator: placebo
soy bean oil
Dietary supplement: Placebo
soy bean oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 0,1,2,4,8,12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota
Time Frame: week 0,12
gut microbiota
week 0,12
inflammatory cytokines (IL-6, hsCRP)
Time Frame: week 0,12
blood inflammatory cytokines
week 0,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2021

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH109-REC3-129

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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