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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
olive oil ethyl esters
China Medical University
Taichung, Taiwan
Change in Hamilton Depression Scale(HAM-D) score at 3 months
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
Change in Beck's Depression Inventory(BDI) score at 3 months
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
Electrocardiogram (EKG)
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
mini nutritional assessment (MNA) score
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
Adverse effects
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
plasma level of n-3 polyunsaturated fatty acids
Time frame: Week 0, Week 12
plasma cytokine/chemokine
Time frame: Week 0, Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.