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

临床试验：Omega-3 脂肪酸治疗重度抑郁症：不同

• 批准号: 8174429
• 负责人: Mark Hyman Rapaport
• 金额: $ 3.5万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174429
• 关键词: Acids; Antidepressive Agents; Blood specimen; Cardiology; Cardiovascular Diseases; Cardiovascular system; Clinical Trials; Collaborations; Computer Retrieval of Information on Scientific Projects Database; Development; Diagnosis; Diet; Dietary Supplementation; Dietary intake; Double-Blind Method; Food; Funding; General Hospitals; Grant; Incidence; Individual; Inflammatory; Institution; Intake; Life; Life Style; Lipids; Major Depressive Disorder; Massachusetts; Measures; Mental Depression; Mental disorders; Mood Disorders; National Center for Complementary and Alternative Medicine; National Institute of Mental Health; Omega-3 Fatty Acids; Patients; Placebos; Polyunsaturated Fatty Acids; Process; Randomized; Relative (related person); Research; Research Personnel; Resources; Rest; Site; Societies; Source; Stress; Surface; Testing; Time; Treatment Efficacy; United States National Institutes of Health; Visit; base; clinically significant; eicosapentanoic acid; follow-up; immune function; lipid metabolism; research study

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项名为“Omega-3 脂肪酸治疗重度抑郁症”的研究是 NIH 资助的一项研究，由国家心理健康研究所 (NIMH) 和国家补充与替代医学中心 (NCCAM) 赞助。项目总期限为2005年1月12日至2010年11月30日，与马萨诸塞州总医院合作。 重度抑郁症是一种常见的精神障碍，给人们的生活带来深远的负面影响。尽管有多种治疗方法，但目前抑郁症的治疗方法并不是最佳的。最近，有证据表明，膳食中多不饱和脂肪酸 (PUFA)（例如 omega-3 脂肪酸）的摄入量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 的摄入量急剧减少。与饮食变化同时发生的是，西方社会重度抑郁症的发病率显着增加。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）为特征的现代西方城市生活方式会造成“促炎症”状态，可能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，膳食补充约标准膳食摄入量 5 倍的 omega-3 可能会产生临床上显着的抗抑郁作用；然而，人们对这种效应的机制知之甚少。比较和对比两种主要 omega-3 脂肪酸（二十碳五烯酸 (EPA) 和二十二碳六烯酸 (DHA)）功效的现有信息也很少。 这项研究将主要关注 EPA 与 DHA 与安慰剂治疗重度抑郁症的抗抑郁功效。我们还将研究脂质代谢与免疫功能指标之间的关系。 在整个研究的 5 年里，两个研究中心的整个研究将随机分配总共 300 名被诊断患有重度抑郁症的患者。在接受抗抑郁药治疗的受试者经过一周的清除期后，受试者将被随机分配接受双盲治疗，服用 1 克/天的 EPA、DHA 或安慰剂。此后受试者将每两周接受一次随访（第 2、4、6 周和第 8 周终点）。所有访问都将包括精神病学评估测试。将在第一次和最后一次就诊时进行血液采样，以分析血脂、心血管和免疫学评估。