About this trial
A 12-week, randomized, placebo-controlled trial testing the efficacy of n-3 PUFA treatment (EPA, 2 g/day) in alleviating depressive symptoms in a subgroup of obese subjects with comorbid depression and low n-3 PUFA status (n-3 index \< 8%) (81), from the Taiwanese cohort. Associations with PLA2/COX2 genotypes, lifestyle, nutritional profiles and gut microbiota will also be determined.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Major depressive disorder.
Antidepressant drug-free.
Disqualifiers
Schizophrenia
Mania
Anxiety disorders (except for social phobia and generalized anxiety that are often comorbid with MDD)
Obsessive-compulsive disorder
Trial design
Parallel
Treatments tested in this trial
Eicosapentaenoic acid (omega-3 fatty acid)
Dietary supplement25 participants are assigned
Placebo
Dietary supplement25 participants are assigned
Treatment groups
Trial outcomes
Primary outcomes
Depression Diagnosis
Patients are diagnosed with depression by utilizing the Mini-International Neuropsychiatric Interview (M.I.N.I.). The screening of emotional disturbances has shown that a total score of 4 or more.
Depression Severity
Depression Severity is assessed by utilizing the 17-item Hamilton Depression Rating Scale (HDRS). A score of ≥ 18 shows a significant level of depression.
Depression Severity
Depression Severity is assessed by utilizing the Montgomery-Åsberg Depression Rating Scale (MADRS). A score of ≥ 20 shows a significant level of depression.
Concentration of Omega-3 Profile in Blood
The level of Omega-3 will be assessed by Gas Chromatography based on the retention time.
Secondary outcomes
Stress Measurement
Stress level will be measured by utilizing the Perceived Stress Scale. A score of 26 is considered a reference point for high, potentially clinically significant stress.
Food Frequency Assessment
Food Frequency Assessment will be measured by using the Food Frequency Questionnaire (FFQ). Statistical thresholds used to identify implausible energy reports, categorize participants by intake levels (e.g., quartiles), or determine high/low risk.
Pleasure Measurement
Pleasure Measurement will be measured by the Snaith-Hamilton Pleasure Scale (SHPS). Score of 3 or more (with a range of 0-14) to indicate the presence of significant anhedonia
Fatigue Measurement
Fatigue will be measured by the Multidimensional Fatigue Inventory (MFI). A total score of 60 or higher is considered indicative of clinically significant fatigue.
Sponsors and contacts
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National Science and Technology Council, Taiwan
Lead sponsor
Ministry of Science and Technology, Taiwan
Sponsor institution
Fondation FondaMental
Collaborator
Fondation pour la Recherche Médicale (FRM)
Collaborator
Ministry of Science and Technology, Taiwan
Collaborator