Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases
2019年7月22日 更新者：Pei-Chen Chang、China Medical University Hospital
Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Taichung、台湾、404
- China Medical University
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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).
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2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
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安慰剂比较：placebo
olive oil ethyl esters
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olive oil ethyl esters
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in Hamilton Depression Scale(HAM-D) score at 3 months
大体时间：Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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Change in Beck's Depression Inventory(BDI) score at 3 months
大体时间：Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Electrocardiogram (EKG)
大体时间：Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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mini nutritional assessment (MNA) score
大体时间：Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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Adverse effects
大体时间：Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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plasma level of n-3 polyunsaturated fatty acids
大体时间：Week 0, Week 12
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Week 0, Week 12
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plasma cytokine/chemokine
大体时间：Week 0, Week 12
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Week 0, Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月27日
初级完成 (实际的)
2017年3月31日
研究完成 (实际的)
2017年6月30日
研究注册日期
首次提交
2017年2月24日
首先提交符合 QC 标准的
2017年3月2日
首次发布 (实际的)
2017年3月7日
研究记录更新
最后更新发布 (实际的)
2019年7月23日
上次提交的符合 QC 标准的更新
2019年7月22日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
n-3 Polyunsaturated fatty acid的临床试验
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Tehran University of Medical Sciences完全的
-
Tehran University of Medical Sciences完全的
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Universidade Nova de LisboaCentro de Investigação Operacional da Beira, Mozambique; Fundação Belmiro de Azevedo, Portugal主动，不招人
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Nordic Pharma, USANutrasource Pharmaceutical and Nutraceutical Services, Inc.完全的
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Tehran University of Medical Sciences完全的