N-乙酰半胱氨酸作为辅助药物治疗伴有炎症活性增加的抗抑郁药物治疗抵抗的重度抑郁症患者：一项双盲随机安慰剂对照试验的研究方案。
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.
机构信息
Tianjin Mental Health Institute, Tianjin Anding Hospital, No.13 Liulin Road, Hexi District, Tianjin, China.
University of Groningen, University Medical Center Groningen, Department of Psychiatry, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.
出版信息
BMC Psychiatry. 2018 Sep 4;18(1):279. doi: 10.1186/s12888-018-1845-1.
BACKGROUND
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.
METHODS/DESIGN: 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.
DISCUSSION
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.
TRIAL REGISTRATION
The trial protocol has been registered on "ClinicalTrials.gov"with protocol ID "NAC-2015-TJAH" and ClinicalTrials.gov ID " NCT02972398 ".
背景
研究表明，有一部分抑郁患者炎症活动增加，他们更容易发展为难治性抑郁症（TRD）。早期的抗炎药物研究显示，这些药物对治疗重度抑郁症（MDD）有一定的疗效，但在炎症活动增加的患者中，预计效果会更高。在持续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结果产生积极影响。因此，本研究旨在探讨 NAC 补充剂对标准抗抑郁治疗反应不足的患者的疗效，并探讨炎症和氧化应激在所谓的 TRD 病理生理过程中所起的作用。
方法/设计：这是一项双盲随机安慰剂对照研究，比较 NAC 与安慰剂作为附加药物，用于治疗 TRD 且炎症活动增加的患者，疗程为 12 周，随访 8 周。除了临床疗效（定义为汉密尔顿抑郁量表（HAMD）-17 评分的变化）外，次要结果还包括与抑郁相关的病理生理机制的变化，以及局部脑活动（功能磁共振成像，fMRI）和白质完整性（弥散张量成像，DTI）的变化。重要的是，仅纳入 CRP 水平在 0.85 至 10mg/L 之间的患者。
讨论
这是第一个将 TRD 和炎症活动增加同时作为纳入标准的临床试验。该研究将为 NAC 治疗炎症活动增加的 TRD 患者的疗效提供可靠的证据。该研究还将有助于进一步探讨炎症和氧化应激在 TRD 所谓的病理生理过程中的作用。
试验注册
该试验方案已在“ClinicalTrials.gov”上注册，方案 ID 为“NAC-2015-TJAH”，ClinicalTrials.gov ID 为“NCT02972398”。
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