NCT07363551

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021May 2026

Study Start

First participant enrolled

June 9, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

April 25, 2024

Last Update Submit

January 22, 2026

Conditions

ADHD

Keywords

omega-3, ADHD

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • gut microbiota

    week 0,12

  • inflammatory cytokines (IL-6, hsCRP)

    week 0,12

Study Arms (2)

omega-3

ACTIVE COMPARATOR

EPA

Combination Product: Omega-3 fatty acids

placebo

PLACEBO COMPARATOR

soy bean oil

Dietary Supplement: Placebo

Interventions

Omega-3 fatty acidsCOMBINATION_PRODUCT

omega-3 fatty acids (EPA)

omega-3
PlaceboDIETARY_SUPPLEMENT

soy bean oil

placebo

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth with a DSM-5 diagnosis of MDE

You may not qualify if:

  • Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.
  • Allergic to omega-3 fatty acids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: To investigate the effects of omega-3 in youth with depression
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

April 25, 2024

First Posted

January 23, 2026

Study Start

June 9, 2021

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

TW(1)