N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes

National Science Council, Taiwan

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Dietary Supplement: Omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT03871088

NHRI-EX105-10528NI

Details and patient eligibility

About

Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.

Full description

In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the diagnostic criteria of DSM-IV for MDD
• 18 to 65 years old
• pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
• physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
• have not received any psychiatric treatment in 2 weeks
• competent to receive a full explanation of this study and give written informed consent.

Exclusion criteria

• a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
• AxisII diagnoses, including borderline and antisocial personality disorder
• a notable medical comorbidity
• acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
• regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups

Eicosapentaenoic acid (EPA)

Active Comparator group

Description:

Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3).

Treatment:

Dietary Supplement: Omega-3 fatty acids

Docosahexaenoic acid (DHA)

Experimental group

Description:

Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3).

Treatment:

Dietary Supplement: Omega-3 fatty acids

EPA/DHA combination

Active Comparator group

Description:

EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids.

Treatment:

Dietary Supplement: Omega-3 fatty acids