Anti-inflammatory treatment of depression: study protocol for a randomised controlled trial of vortioxetine augmented with celecoxib or placebo.
Anti-inflammatory treatment of depression: study protocol for a randomised controlled trial of vortioxetine augmented with celecoxib or placebo.
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DOI：
10.1186/s13063-018-2829-7
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发表时间：
2018-08-20
期刊：
影响因子：
2.5
通讯作者：
Baune BT
中科院分区：
文献类型：
--
作者：
Fourrier C;Sampson E;Mills NT;Baune BT
在重度抑郁症（MDD）患者中，抗抑郁药的反应和缓解率很低，这突出了对新治疗方法的需求。最近，大量的文献将炎症过程和抑郁症状联系起来，这导致了一种假设，即根据患者的炎症状态选择MDD治疗可能是改善MDD患者结局的一种有前途的策略。我们提出的随机对照试验的目的是研究在炎症水平升高的个体中，抗抑郁药物加抗炎药物联合治疗MDD的抗抑郁疗效。这项研究将首次采用随机对照试验设计，基于MDD患者的基线炎症标志物水平，前瞻性地测试抗抑郁药加抗炎增强的疗效。本研究拟在200例MDD患者开始治疗前测量血液C反应蛋白（CRP）水平。然后将研究参与者分配到两个研究分层中的一个：进入“伴有炎症的抑郁症”分层（CRP水平> 3 mg/L）;或进入“无炎症的抑郁症”分层（CRP水平≤ 3 mg/L）。在两个研究分层中，参与者随机接受单独的抗抑郁药物（沃替西汀）加抗炎药物（塞来昔布）或沃替西汀加安慰剂六周。在治疗期结束时，参与者有机会在试验后6个月内继续单独使用沃替西汀。在基线、治疗期间每两周以及试验后三个月和六个月访视时测量临床结果。主要结局是MADRS评分的变化，主要终点是6周（塞来昔布增强治疗结束）评分较基线降低50%。次要临床结局是抑郁症认知维度（认知功能、情绪处理和社会认知）的变化。在基线、治疗6周后和试验后6个月访视时测量生物学结果指标（CRP和其他炎症标志物的水平）。目前的研究将根据患者治疗前的炎症状态，为基于生物标志物的个性化抗抑郁治疗选择提供新的证据。澳大利亚新西兰临床试验注册中心（ANZCTR），ACTRN 12617000527369 p。于2017年4月11日注册。本文的在线版本（10.1186/s13063-018-2829-7）包含补充材料，可供授权用户使用。
In patients with major depressive disorder (MDD), antidepressant response and remission rates are low, highlighting the need for new treatment approaches. Recently, the abundant literature linking inflammatory processes and depressive symptoms have led to the hypothesis that selecting treatment for MDD based on the patient’s inflammatory status could be a promising strategy to improve outcomes in patients suffering from MDD. The aim of the randomised control trial we propose is to investigate the antidepressant efficacy of the combined treatment of MDD with antidepressant medication plus anti-inflammatory medication in individuals with raised inflammation levels. For the first time, this study will prospectively test the efficacy of an antidepressant plus anti-inflammatory augmentation based on baseline inflammatory maker levels in MDD using a randomised controlled trial design. This study proposes to measure blood C-reactive protein (CRP) levels before the initiation of treatment in 200 participants with MDD. Study participants are then assigned into one of two study strata: either into the ‘Depression with inflammation’ stratum (CRP levels > 3 mg/L); or into the ‘Depression without inflammation’ stratum (CRP levels ≤ 3 mg/L). Within each of the two study strata, participants randomly receive either antidepressant medication alone (vortioxetine) plus anti-inflammatory medication (celecoxib) or vortioxetine plus placebo for six weeks. At the end of the treatment period, participants have the opportunity to continue vortioxetine alone for a six-month post-trial period. Clinical outcomes are measured at baseline, fortnightly during the treatment period and at the three-month and six-month post-trial visits. The primary outcome is change in MADRS score, with a primary endpoint of a score reduction by 50% from baseline to six weeks (end of augmentation treatment with celecoxib). Secondary clinical outcomes are changes in the cognitive dimensions of depression (cognitive function, emotion processing and social cognition). Biological outcome measures (levels of CRP and other inflammatory markers) are measured at baseline, after six weeks of treatment and at the six-month post-trial visit. The current study will generate novel evidence for biomarker-based personalised antidepressant treatment selection based on patient inflammatory status before treatment. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017. The online version of this article (10.1186/s13063-018-2829-7) contains supplementary material, which is available to authorized users.
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