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

China Medical University

Status: Enrolling

Conditions: ADHD

Treatments: Combination Product: Omega-3 fatty acids; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07363551

CMUH109-REC3-129

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

omega-3

Active Comparator group

Description:

EPA

Treatment:

Combination Product: Omega-3 fatty acids

placebo

Placebo Comparator group

Description:

soy bean oil

Treatment:

Dietary Supplement: Placebo