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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and physical health by reducing membrane arachidonic acid (AA) and prostaglandin E2 (PGE2) synthesis, which might be linked to the somatic manifestations physical morbidity, such as Cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a promising treatment that is safe, beneficial to patients with Cardiovascular disease and depression. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in treating Cardiovascular disease patients with major depression after 12 weeks of intervention.
This is a 3-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enroll 60 subjects from cardiovascular department of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the depressive symptoms ( using Hamilton Depression Scale, HAM-D, and Beck Depression Inventory, BDI ) of the subjects who are enrolled into the study will take place at -1st, 0, 2nd, 4th, 8th, 12th week. The plasma level of n-3 polyunsaturated fatty acids, chemokines/cytokines, and Electrocardiogram will also be measured at the beginning and at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-3 polyunsaturated fatty acids | Active Comparator | n-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA). |
|
| placebo | Placebo Comparator | olive oil ethyl esters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-3 Polyunsaturated fatty acid | Dietary Supplement | 2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Scale(HAM-D) score at 3 months | Week 0, Week 2, Week 4 Week 8, Week 12 | |
| Change in Beck's Depression Inventory(BDI) score at 3 months | Week 0, Week 2, Week 4 Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram (EKG) | Week 0, Week 2, Week 4 Week 8, Week 12 | |
| mini nutritional assessment (MNA) score | Week 0, Week 2, Week 4 Week 8, Week 12 | |
| Adverse effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Taichung | 404 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34817851 | Derived | Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| placebo | Dietary Supplement | olive oil ethyl esters |
|
| Week 0, Week 2, Week 4 Week 8, Week 12 |
| plasma level of n-3 polyunsaturated fatty acids | Week 0, Week 12 |
| plasma cytokine/chemokine | Week 0, Week 12 |
| D001519 |
| Behavior |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |