• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMC Psychiatry >N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial
【24h】

N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

机译：N-乙酰半胱氨酸作为治疗性难治性重度抑郁症患者的抗抑郁药，其炎症活动增强：双盲随机安慰剂对照试验的研究方案

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A subgroup of depressed patients with increased inflammatory activity was shown to be more susceptible to develop Treatment Resistant Depression (TRD). Earlier studies with anti-inflammatory drugs have shown benefits in the treatment of major depressive disorder (MDD), but the effects are expected to be higher in patients with increased inflammatory activity. Supplementation of N-acetylcysteine (NAC) to ongoing antidepressant therapy may positively influence outcome of depression treatment in these patients. Therefore, this study aims to investigate the efficacy of NAC supplementation in patients with insufficient response to standard antidepressant treatment, and to explore potential roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD. A double-blind randomized placebo-controlled study comparing NAC versus placebo as add-on medication to antidepressant treatment with 12-week treatment and 8-week follow up in patients with TRD and increased inflammatory activity. Apart from clinical efficacy defined as the change in Hamilton Depression Rating Scale (HAMD)-17 score, secondary outcomes include changes in pathophysiological mechanisms related to depression as well as changes in local brain activity (functional Magnetic Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). Importantly, sole patients with CRP levels with values between 0.85 and 10?mg/L will be included. This is the first clinical trial taking both TRD and increased inflammatory activity as inclusion criteria. This study will provide reliable evidence for the efficacy of NAC in patients with TRD displaying increased inflammatory activity. And this study also will help explore further the roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD. The trial protocol has been registered on “ClinicalTrials.gov“with protocol ID “NAC-2015-TJAH” and ClinicalTrials.gov ID “ NCT02972398 ”.
机译：已显示，炎症活动增强的抑郁症患者亚组更容易发展为抗药性抑郁症（TRD）。早期使用抗炎药的研究已显示出对重度抑郁症（MDD）的治疗有益处，但预期在炎症活动增加的患者中这种作用会更高。在正在进行的抗抑郁治疗中补充N-乙酰半胱氨酸（NAC）可能会对这些患者的抑郁治疗产生积极影响。因此，本研究旨在研究补充NAC对标准抗抑郁药治疗反应不足的患者的疗效，并探讨炎症和氧化应激在TRD所谓病理生理过程中的潜在作用。一项双盲随机安慰剂对照研究，比较了患有TRD和炎症活动增加的患者，NAC与安慰剂作为抗抑郁药的附加药物进行12周治疗和8周随访。除了定义为汉密尔顿抑郁量表（HAMD）-17得分变化的临床疗效外，次要结局包括与抑郁相关的病理生理机制的变化以及局部脑活动的变化（功能磁共振成像，fMRI）和白质完整性（扩散张量成像，DTI）。重要的是，将包括CRP水平在0.85至10？mg / L之间的唯一患者。这是第一个以TRD和增加的炎症活性为纳入标准的临床试验。这项研究将为NAC在TRD患者中表现出炎性活性增加的疗效提供可靠的证据。这项研究也将有助于进一步探索炎症和氧化应激在TRD所谓病理生理过程中的作用。该试验方案已在“ ClinicalTrials.gov”上注册，方案ID为“ NAC-2015-TJAH”，临床方案ID为“ NCT02972398”。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号