CLINICAL TRIAL: OMEGA-3 FATTY ACIDS FOR TREATMENT OF MAJOR DEPRESSION: DIFFERENT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项名为“欧米茄-3脂肪酸治疗抑郁症”的研究是由美国国立卫生研究院资助的，由国家精神卫生研究所(NIMH)和国家补充与替代医学中心(NCCAM)赞助。整个项目期从2005年1月12日到2010年11月30日，与马萨诸塞州综合医院合作。 由于抑郁症是一种常见的精神障碍，它对S的生活有深刻的负面影响。尽管有许多治疗方法可用，但目前的抑郁症治疗并不是最理想的。最近，有证据表明，饮食中多不饱和脂肪酸(PUFAs)的摄入量，如omega-3脂肪酸，可能与抑郁症和心血管疾病有关。在过去的一个世纪里，西方饮食中omega-3脂肪酸的摄入量相对于omega-6的摄入量大幅下降。与饮食的这种变化相一致的是，在西方社会，严重抑郁障碍的发生率显著增加。有人认为，这种以高压力、少休息和大量摄入加工食品(即富含omega-6的食物)为特征的现代西方城市生活方式会造成一种促炎状态，这可能会导致某些人出现情绪障碍。心脏病研究表明，omega-3补充剂可以纠正这种omega-6：omega-3比例失衡，并逆转这种促炎状态。最近的研究还表明，在标准膳食摄入量的5倍左右补充omega-3可能会产生临床上显着的抗抑郁作用；然而，人们对这种作用的机制知之甚少。目前对两种主要的omega-3脂肪酸，二十碳五酸(EPA)和二十二碳六酸(DHA)的疗效进行比较和对比的现有信息也很少。 这项研究将主要集中在EPA、DHA和安慰剂治疗重度抑郁症中的抗抑郁疗效。我们还将研究脂代谢与免疫功能指标之间的关系。 这两个研究地点的整个研究将在整个5年的研究中随机选择总共300名被诊断为严重抑郁障碍的患者。在服用抗抑郁药物的受试者进行为期一周的冲洗期后，受试者将被随机分配到双盲治疗组，每天服用1克EPA、DHA或安慰剂。此后，受试者将每两周进行一次随访(第2、4、6周和第8周的终点)。所有探视将包括精神评估测试。将在第一次和最后一次就诊时进行血液采样，以分析血脂情况、心血管和免疫学评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study entitled "Omega-3 Fatty Acids for Treatment of Major Depression" is an NIH funded grant, sponsored by the National Institute for Mental Health (NIMH) and the National Center for Complementary & Alternative Medicine (NCCAM). The total project period is from 12/01/2005 through 11/30/2010 and is in collaboration with Massachusetts General Hospital. As major depression is a common mental disorder, it has a profound negative impact on people¿s lives. Despite the availability of numerous therapies, the current treatment of depression is not optimal. Recently, evidence has surfaced suggesting that the dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acid, might be related to depression and cardiovascular disease. The intake of omega-3 fatty acids in the western diet has decreased dramatically relative to omega-6 intake over the past century. Coincident with this change in diet, the incidence of major depressive disorder has markedly increased in western societies. It has been suggested that this modern western urban lifestyle characterized by high stress, little rest, and high intake of processed (i.e. omega-6-rich) foods creates a ¿pro-inflammatory¿ state that may contribute to the development of mood disorders in some individuals. As been demonstrated in cardiology research studies, omega-3 supplements may correct this omega-6:omega-3 ratio imbalance, and reverse this pro-inflammatory state. Recent studies also suggest that omega-3 dietary supplementation at about 5 times the standard dietary intake may yield clinically significant antidepressant effects; however little is known about the mechanisms of this effect. There is also little existing information comparing and contrasting the efficacy of the two major omega-3 fatty acids, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). This study will focus primarily the antidepressant efficacy of therapy with EPA vs. DHA vs. placebo in the treatment of major depression. We will also investigate the relationship between lipid metabolism and measures of immune function. The entire study at both study sites will randomize a total of 300 patients diagnosed with major depressive disorder over the entire 5 years of this study. Following a one-week washout period for subjects on antidepressants, subjects will be randomly assigned to double-blind treatment with either 1 gram/day EPA, DHA, or placebo. Subjects will undergo follow-up visits on a bi-weekly basis thereafter (weeks 2, 4, 6, and week 8 endpoint). All visits will include psychiatric assessment testing. Blood sampling will be performed at the first and last visits for analysis of lipid profiles, cardiovascular, and immunological assessments.