Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Hamilton Depression Scale(HAM-D) score at 3 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cardiovascular disease patients
- •The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
- •Capacity and willingness to give written informed consent.
Exclusion Criteria
- •cognitive impairment (Mini-mental state examination score <24)
- •comorbid psychiatric disorders, psychosis, high risk of suicide, current substance use
- •an acute coronary syndrome within previous 2 months, left ventricular ejection fraction (LVEF)<30%, advanced malignancy, or physical inability to participate
- •use of antidepressants, anticonvulsants, lithium, or n-3 polyunsaturated fatty acids supplements
- •coagulation disorders or sensitivity to n-3 polyunsaturated fatty acids
Arms & Interventions
placebo
olive oil ethyl esters
Intervention: placebo (Dietary Supplement)
n-3 polyunsaturated fatty acids
n-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA).
Intervention: n-3 Polyunsaturated fatty acid (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- plasma level of n-3 polyunsaturated fatty acids(Week 0, Week 12)
- plasma cytokine/chemokine(Week 0, Week 12)
- Adverse effects(Week 0, Week 2, Week 4 Week 8, Week 12)
Investigators
Pei-Chen Chang
Attending Physician
China Medical University Hospital