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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07363551

Acronym

OMIMYDep

Enrollment

Registered

2026-01-23

Start date

2021-06-09

Completion date

2026-05-31

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

omega-3, ADHD

Brief summary

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_PRODUCTOmega-3 fatty acids

omega-3 fatty acids (EPA)

DIETARY_SUPPLEMENTPlacebo

soy bean oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind

Intervention model description

To investigate the effects of omega-3 in youth with depression

Eligibility

Sex/Gender

ALL

Age

13 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
clinical symptoms	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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026