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Recruiting NCT07363551

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

No phase Interventional ADHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omega-3 fatty acids, Placebo.
Who it may be relevant to
Registry conditions: ADHD. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Combination product Omega-3 fatty acids
    omega-3 fatty acids (EPA)
  • Dietary supplement Placebo
    soy bean oil

Primary outcome measures

  • clinical symptoms [Time frame: week 0,1,2,4,8,12]
Secondary outcome measures (2)
  • gut microbiota [Time frame: week 0,12]
  • inflammatory cytokines (IL-6, hsCRP) [Time frame: week 0,12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University — Taichung

Identifiers

NCT: NCT07363551 · CMUH109-REC3-129

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗