Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy.
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy.
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DOI：
10.1186/s13063-021-05730-7
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发表时间：
2021-11-08
期刊：
影响因子：
2.5
通讯作者：
Blumberger DM
中科院分区：
文献类型：
--
作者：
Daskalakis ZJ;Tamminga C;Throop A;Palmer L;Dimitrova J;Farzan F;Thorpe KE;McClintock SM;Blumberger DM
电休克治疗(ECT)对难治性抑郁症(TRD)是行之有效的，但在加拿大和美国，只有不到1%的难治性抑郁症患者接受ECT治疗，主要是因为它的认知不良反应(即健忘症)。因此，迫切需要新的治疗TRD的替代方案。其中一种治疗方法是磁癫痫疗法(MST)。ECT包括施加一系列高频电刺激来诱导癫痫发作，而MST涉及施加一系列高频磁刺激来诱发癫痫发作。在这篇论文中，我们介绍了我们的国际化、双部位、双盲、随机、非劣势的临床试验，以开发MST作为一种有效而安全的治疗TRD的方法。这项试验将在260名TRD患者中比较MST和右侧超短脉冲宽度电惊厥疗法(RUL-UB-ECT)的疗效，其中RUL-UB-ECT的主要终点是抑郁缓解和认知不良反应。自杀意念的改善将被评估为次要终点。住院患者或门诊患者，年龄在18岁以上，进行了小型国际神经精神病学访谈(MINI)诊断为非精神病型严重抑郁障碍，只要他们符合病情严重程度和完全符合资格标准，就可以参加研究。参与者随机接受MST或RUL-UB ECT，在七周内每周接受2-3次 治疗，或最多接受21次治疗。这项研究将涉及与意向治疗研究设计方法一致的抑郁症严重程度、自杀意念、主观副作用和认知表现的治疗前、治疗中和治疗后评估。这项试验的积极结果可能对TRD患者产生立竿见影的巨大影响。如果MST显示出与ECT类似的抗抑郁治疗效果，但认知安全性更高，它可能会迅速应用于临床实践。事实上，鉴于MST的管理几乎与ECT相同，北美的大多数ECT设施都可以很容易地采用MST。此外，认知安全的潜力可能会提高治疗的可接受性。因此，医疗保健提供者、患者和护理合作伙伴以及政策制定者将要求这种形式的抽搐治疗。这项研究于2018年6月26日开始招生，预计2024年7月完成招生。截至提交时，我们已经招募了117名参与者并对其进行了随机分配。ClinicalTrials.gov NCT03191058,2017年6月19日注册。主要赞助商：dmb，首席调查员daniel.blumberger@camh.ca，416--8501 x 33662公共查询联系人：dmb，daniel.blumberger@camh.ca科学查询联系人：zjd，zdaskalakis@Health.ucsd.edu在线版本包含补充材料，可通过10.1186/s13063-021-05730-7查询。
Electroconvulsive therapy (ECT) is well-established and effective for treatment-resistant depression (TRD), but in Canada and the USA, less than 1% of patients with TRD receive ECT mainly due to its cognitive adverse effects (i.e. amnesia). Thus, new treatment alternatives for TRD are urgently needed. One such treatment is magnetic seizure therapy (MST). ECT involves applying a train of high-frequency electrical stimuli to induce a seizure, whereas MST involves applying a train of high-frequency magnetic stimuli to induce a seizure. In this manuscript, we introduce our international, two-site, double-blinded, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. This trial will compare the efficacy of MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT) with a combined primary endpoint of remission of depression and superior cognitive adverse effects in 260 patients with TRD. Amelioration of suicidal ideation will be assessed as a secondary endpoint. Inpatients or outpatients, over 18 years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD) can be enrolled in the study provided that they meet illness severity and full eligibility criteria. Participants are randomized to receive MST or RUL-UB ECT, 2-3 days per week over seven weeks, or a maximum of 21 treatments. The study will involve before-, during-, and after-treatment assessments of depression severity, suicidal ideation, subjective side-effects, and cognitive performance consistent with an intent-to-treat study design approach. Positive results from this trial could have an immediate and tremendous impact for patients with TRD. If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice. Indeed, given that the administration of MST is nearly identical to ECT, the majority of ECT facilities in North America could readily adopt MST. Furthermore, the potential for cognitive safety could lead to improved treatment acceptability. Healthcare providers, patients and care partners, and policymakers would therefore demand this form of convulsive therapy. Enrollment for this study began on June 26, 2018, and is estimated to complete recruitment by July 2024. At the time of submission, we have enrolled and randomized 117 participants. ClinicalTrials.gov NCT03191058, Registered on June 19, 2017. Primary sponsor: Daniel Blumberger (DMB), Principal Investigator Daniel.Blumberger@camh.ca, 416-535-8501 x 33662 Contact for public queries: DMB, Daniel.Blumberger@camh.ca Contact for scientific queries: ZJD, Zdaskalakis@health.ucsd.edu The online version contains supplementary material available at 10.1186/s13063-021-05730-7.
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影响因子：
4.8
作者：
Kayser, Sarah;Bewernick, Bettina H.;Schlaepfer, Thomas E.
通讯作者：
Schlaepfer, Thomas E.
影响因子：
7.6
作者：
Lisanby, SH;Luber, B;Sackeim, HA
通讯作者：
Sackeim, HA
影响因子：
5.9
作者：
BECK, AT;KOVACS, M;WEISSMAN, A
通讯作者：
WEISSMAN, A
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
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通讯作者：
Moher D
影响因子：
4
作者：
Deng, Zhi-De;Lisanby, Sarah H.;Peterchev, Angel V.
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