Cardiovascular Diseases, Major Depressive Disorder
Conditions
Keywords
CVDs, cardiovascular diseases, n-3 polyunsaturated fatty acids, depression
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTn-3 Polyunsaturated fatty acid
2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
DIETARY_SUPPLEMENTplacebo
olive oil ethyl esters
Sponsors
National Science and Technology Council, Taiwan
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cardiovascular disease patients 2. The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. 3. Capacity and willingness to give written informed consent.
Exclusion criteria
1. cognitive impairment (Mini-mental state examination score \<24) 2. comorbid psychiatric disorders, psychosis, high risk of suicide, current substance use 3. an acute coronary syndrome within previous 2 months, left ventricular ejection fraction (LVEF)\<30%, advanced malignancy, or physical inability to participate 4. use of antidepressants, anticonvulsants, lithium, or n-3 polyunsaturated fatty acids supplements 5. coagulation disorders or sensitivity to n-3 polyunsaturated fatty acids
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects | Week 0, Week 2, Week 4 Week 8, Week 12 |
| Electrocardiogram (EKG) | Week 0, Week 2, Week 4 Week 8, Week 12 |
| plasma cytokine/chemokine | Week 0, Week 12 |
| plasma level of n-3 polyunsaturated fatty acids | Week 0, Week 12 |
| mini nutritional assessment (MNA) score | Week 0, Week 2, Week 4 Week 8, Week 12 |
Countries
Taiwan
Outcome results
None listed