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

China Medical University Hospital60 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

ADHD

Interventions

Omega-3 fatty acidsCOMBINATION_PRODUCT

omega-3 fatty acids (EPA)

PlaceboDIETARY_SUPPLEMENT

soy bean oil

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

China Medical University

Taichung, Taichung, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: week 0,1,2,4,8,12

Secondary Outcomes

gut microbiota

Time frame: week 0,12

inflammatory cytokines (IL-6, hsCRP)

blood inflammatory cytokines

Time frame: week 0,12

Data from ClinicalTrials.gov

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