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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项名为“Omega-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）和国家补充和替代医学中心（NCCAM）赞助。项目总周期为2005年1月12日至2010年11月30日，与马萨诸塞州总医院合作。 由于重性抑郁症是一种常见的精神疾病，它对人们的生活产生了深远的负面影响。尽管有多种疗法，但目前抑郁症的治疗并不是最佳的。最近，有证据表明，膳食中摄入多不饱和脂肪酸（PUFA），如欧米茄-3脂肪酸，可能与抑郁症和心血管疾病有关。在过去的世纪里，西方饮食中omega-3脂肪酸的摄入量相对于omega-6脂肪酸的摄入量急剧下降。与这种饮食变化相一致的是，在西方社会，重度抑郁症的发病率明显增加。有人认为，这种现代西方城市生活方式的特点是高压力，很少休息，以及大量摄入加工食品（即富含omega-6），这可能会导致某些人出现情绪障碍。正如心脏病学研究所证明的那样，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，以约5倍于标准膳食摄入量的omega-3膳食补充剂可能产生临床显著的抗抑郁作用;然而，对这种作用的机制知之甚少。也几乎没有现有的信息比较和对比两种主要的ω-3脂肪酸，二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）的功效。 本研究将主要关注EPA与DHA与安慰剂治疗重度抑郁症的抗抑郁疗效。我们还将研究脂质代谢和免疫功能指标之间的关系。 在整个研究的5年期间，两个研究中心的整个研究将随机分配总共300名诊断为重度抑郁症的患者。在抗抑郁药治疗受试者的一周洗脱期后，受试者将被随机分配接受1克/天EPA、DHA或安慰剂的双盲治疗。此后，受试者将每两周接受一次随访访视（第2、4、6周和第8周终点）。所有访视将包括精神病评估测试。将在首次和末次访视时采集血样，用于血脂分析、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.