The Third Clinical College, Guangzhou Medical University, Guangzhou, China.
PsyNI Lab, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.
BMJ Open. 2021 Feb 12;11(2):e043457. doi: 10.1136/bmjopen-2020-043457.
Despite a range of antidepressant drugs and therapies, approximately one-third of patients fail to achieve meaningful recovery, prompting the urgent need for more effective treatment for depression. Several open-label studies randomised controlled trials (RCTs) and meta-analyses have been conducted to confirm the therapeutic efficacy and side effects of ketamine and esketamine. Esketamine is (S)- enantiomer of ketamine; however, there is limited evidence comparing esketamine and ketamine in treating unipolar and bipolar depression have been published so far.
We will include all double-blind RCTs comparing efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression. Our primary outcomes will be study-defined response at endpoint assessment; dropouts due to adverse events and other adverse drug reactions. Published studies will be retrieved through relevant database searches. Reference selection and data extraction will be independently completed by two investigators, resolving inconsistencies by consensus or a discussion with the third investigator. For each outcome, we will undertake a network meta-analysis to synthesise all evidence. Local and global methods will be used to evaluate consistency. We will assess the quality of evidence contributing to network estimates with the Confidence in Network Meta-Analysis web application.
This work does not require ethics approval as it will be based on published studies. This review will be published in peer-reviewed journals.
CRD42020201559.
尽管有多种抗抑郁药和疗法，但约三分之一的患者未能实现有意义的康复，这促使人们迫切需要更有效的抑郁症治疗方法。已经进行了几项开放标签研究、随机对照试验 (RCT) 和荟萃分析，以确认氯胺酮和 Esketamine 的治疗效果和副作用。Esketamine 是氯胺酮的 (S)-对映异构体；然而，迄今为止，关于 Esketamine 和氯胺酮在治疗单相和双相抑郁症方面的疗效比较的证据有限。
我们将纳入所有比较氯胺酮和 Esketamine 在单相和双相抑郁症治疗中的疗效和副作用的双盲 RCT。我们的主要结局将是在终点评估时定义的研究应答；因不良事件和其他不良反应而退出。将通过相关数据库搜索检索已发表的研究。参考文献选择和数据提取将由两名研究人员独立完成，通过共识或与第三名研究人员讨论解决不一致之处。对于每个结局，我们将进行网络荟萃分析以综合所有证据。局部和全局方法将用于评估一致性。我们将使用 Confidence in Network Meta-Analysis 网络应用程序评估对网络估计有贡献的证据质量。
这项工作不需要伦理批准，因为它将基于已发表的研究。本综述将发表在同行评议的期刊上。
PROSPERO 注册号：CRD42020201559。
