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

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

Detailed Description
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eicosapentaenoic acid (EPA)<br>Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3). | Dietary Supplement: Omega-3 fatty acids<br>* 12-week double-blind, randomized controlled trial<br>|
| Experimental: Docosahexaenoic acid (DHA)<br>Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3). | Dietary Supplement: Omega-3 fatty acids<br>* 12-week double-blind, randomized controlled trial<br>|
| Active Comparator: EPA/DHA combination<br>EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids. | Dietary Supplement: Omega-3 fatty acids<br>* 12-week double-blind, randomized controlled trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAMD) Changes | The Changes of scores in Hamilton Rating Scale for Depression | From Week 0 to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | 50% decreases in the Hamilton Rating Scale for Depression from W0 to W12 | at Week 12 | 
| Remission rate | Less than 8 points in the Hamilton Rating Scale for Depression at W12 | at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, omega-3 fatty acids, nutritional intervention