S-Adenosyl Methionine(SAMe)Augmentation of SSRIs in MDD

S-腺苷甲硫氨酸 (SAMe) 增强 SSRIs 在 MDD 中的作用

• 批准号: 6847114
• 负责人: George I Papakostas
• 金额: $ 17.48万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-01-27 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6847114
• 关键词: S adenosylmethionine; alternative medicine; antidepressants; blood cell count; clinical research; electrocardiography; homocysteine; human subject; human therapy evaluation; interview; major depression; mental disorder chemotherapy; miscellaneous oxidoreductase; patient oriented research; psychopharmacology; questionnaires; serotonin inhibitor; statistics /biometry

DESCRIPTION (provided by candidate): This is a submission of an application for a mentored patient-oriented K-23 award, designed to enhance clinical training and research expertise in the area of major depressive disorder on (MDD) and the role of natural remedies in the development and treatment of depressive disorders. Natural remedies, although used for centuries throughout the world, have become increasingly popular in the US over the past few years. S-adenosyl methionine (SAMe) is one such compound. Although results obtained from double-blind preliminary studies support the hypothesis that this compound may have antidepressant effects, oral SAMe has not yet been studied as a potential augmenting agent for contemporary, first-line antidepressants, such as the Selective Serotonin Reuptake Inhibitors (SSRIs). As many as 29% to 46% of depressed patients show only partial or non-response to an adequate course of an antidepressant, with most patients taking an SSRI as an initial treatment. The goal of this project will be to assess the efficacy of oral SAMe compared to placebo as an augmentor of SSRIs in the treatment of major depression refractory to treatment with SSRIs. This application involves enrolling outpatients with MDD, with partial or no response to an SSRI trial of adequate dose and duration. Patients will be treated for 6 weeks in a double-blind fashion with either oral SAMe tosylate, up to 1600mg/day, or placebo for 6 weeks. We hypothesize that there will be a statistically significant difference in the response rates between the two treatment groups at endpoint, with a greater response rate in the group that received SAMe augmentation. The proposed study will be based at the Massachusetts General Hospital in the Depression Clinical and Research Program, under the mentorship of Maurizio Fava, MD, and will include consultation from experts in the area of MDD, alternative medicine, and biostatistics. There will also be a didactic component to the application project, including coursework research design, neuronal biology, biostatistics, and ethics. It is hoped that this project award will provide the critical fund of basic knowledge and practical experience necessary to aid the candidate in becoming an independent investigator in this area.

描述（由候选人提供）：这是针对受患者的指导K-23奖的申请的提交，旨在增强主要抑郁症（MDD）领域的临床培训和研究专业知识（MDD）以及自然疗法在抑郁症的发展和治疗中的作用。自然疗法虽然在世界各地已有数百年的历史，但在过去的几年中，在美国越来越受欢迎。 S-腺苷蛋氨酸（相同）就是这样的化合物。尽管从双盲初步研究获得的结果支持了这种化合物可能具有抗抑郁作用的假设，但尚未将口服研究作为当代，一线抗抑郁药的潜在增强剂，例如选择性5-羟色胺抗抑郁剂抑制剂（SSRIS）。多达29％至46％的抑郁症患者仅表现出对适当抗抑郁药的部分或无反应，大多数患者将SSRI作为初始治疗。该项目的目的是评估与安慰剂作为SSRIS的增强子相比，在用SSRI治疗治疗重大抑郁症治疗大抑郁症方面的疗效。该申请涉及入学MDD的门诊患者，对适当剂量和持续时间的SSRI试验有部分或没有反应。患者将以双盲方式以两种口服相同的甲基酸盐，每天1600mg或安慰剂治疗6周，持续6周。我们假设在端点，两个治疗组之间的响应率在统计学上会有显着差异，并且该组的响应率更高。拟议的研究将在马里兰州毛里齐奥·法瓦（Maurizio Fava）的指导下，基于抑郁症临床和研究计划的马萨诸塞州综合医院，包括MDD领域的专家，替代医学和生物统计学方面的咨询。该应用程序项目还将有一个教学成分，包括课程研究设计，神经元生物学，生物统计学和伦理学。希望该项目奖将提供基础知识和实践经验的关键基金，以帮助候选人成为该领域的独立调查员。