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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT03871088
• Lead Sponsor: National Science Council, Taiwan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2019-03
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA/DHA combination	Omega-3 fatty acids	EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids.
Eicosapentaenoic acid (EPA)	Omega-3 fatty acids	Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3).
Docosahexaenoic acid (DHA)	Omega-3 fatty acids	Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3).

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAMD) Changes	From Week 0 to Week 12	The Changes of scores in Hamilton Rating Scale for Depression

Secondary Outcome Measures

Name	Time	Method
Response rate	at Week 12	50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
Remission rate	at Week 12	Less than 8 points in the Hamilton Rating Scale for Depression at W12

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan