Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Scale(HAM-D) score at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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).
干预措施: n-3 Polyunsaturated fatty acid (Dietary Supplement)
placebo
olive oil ethyl esters
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Change in Hamilton Depression Scale(HAM-D) score at 3 months
时间窗: Week 0, Week 2, Week 4 Week 8, Week 12
Change in Beck's Depression Inventory(BDI) score at 3 months
时间窗: Week 0, Week 2, Week 4 Week 8, Week 12
次要结局
- plasma level of n-3 polyunsaturated fatty acids(Week 0, Week 12)
- 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 cytokine/chemokine(Week 0, Week 12)
- Adverse effects(Week 0, Week 2, Week 4 Week 8, Week 12)
研究者
Pei-Chen Chang
Attending Physician
China Medical University Hospital