Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Yout... | NCT07363551

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

NCT07363551

Sponsor

China Medical University Hospital

Status

Recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

ADHD

Interventions

Omega-3 fatty acids
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2021Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Apr 25, 2024

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pei-Chen Chang, Consultant Psychiatrist, China Medical University HospitalPrincipal Investigator

Lead Sponsor

China Medical University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
omega-3	Active Comparator	EPA	Combination Product: Omega-3 fatty acids
placebo	Placebo Comparator	soy bean oil	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 fatty acids	Combination Product	omega-3 fatty acids (EPA)	omega-3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical symptoms	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University	Recruiting	Taichung	Taichung	404	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided