Goodman Michelle S, Trevizol Alisson P, Konstantinou Gerasimos N, Boivin-Lafleur David, Brender Ram, Downar Jonathan, Kaster Tyler S, Knyahnytska Yuliya, Vila-Rodriguez Fidel, Voineskos Daphne, Daskalakis Zafiris J, Blumberger Daniel M
Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.
Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
Neuropsychopharmacology. 2025 Mar;50(4):685-694. doi: 10.1038/s41386-024-02007-w. Epub 2024 Oct 23.
In response to restrictions on electroconvulsive therapy (ECT) access during COVID-19, we designed a trial to assess the clinical outcomes service impacts, employing an extended course of accelerated intermittent theta burst stimulation (aiTBS), in patients with moderate to severe depression in need of ECT. This open label clinical trial was comprised of 3 phases: (i) an acute phase, where iTBS treatments were administered 8 times daily, for up to 10 days; (ii) a tapering phase of 2 treatment days per week for 2 weeks, followed by 1 treatment day per week for 2 weeks; and (iii) a symptom-based relapse prevention phase, whereby treatments were scheduled based on symptom re-emergence, for up to 6 months. Of the 155 patients who completed the acute phase of the study, the remission rate was 16.1%. The mean reduction from baseline on the HRSD-24 was 29.4% (p < 0.001) and the response rate was 25.2%. Of the 110 patients who completed the tapering phase, the mean reduction from baseline was 42.6% (p < 0.001) and response and remission rates were 49.6% and 34.8%, respectively. Of the 61 patients who were eligible for the relapse prevention phase, 43 completed, with a mean reduction from baseline of 60.1% (p < 0.001); 7 patients relapsed during this phase. This study demonstrated that an extended aiTBS protocol safely led to meaningful clinical outcomes in patients with severe depression, who otherwise would have received ECT, and thus reduced pressure on ECT services during the pandemic. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04384965 ( https://clinicaltrials.gov/study/NCT04384965?term=NCT04384965&rank=1 ).
为应对2019年冠状病毒病（COVID-19）期间电休克治疗（ECT）获取受限的情况，我们设计了一项试验，以评估在需要ECT的中度至重度抑郁症患者中采用延长疗程的加速间歇性theta波刺激（aiTBS）的临床结果和服务影响。这项开放标签的临床试验包括三个阶段：（i）急性期，每天进行8次iTBS治疗，持续至多10天；（ii）减量期，每周进行2天治疗，持续2周，随后每周进行1天治疗，持续2周；（iii）基于症状的复发预防期，根据症状复发安排治疗，持续至多6个月。在完成研究急性期的155名患者中，缓解率为16.1%。HRSD-24从基线的平均降低率为29.4%（p < 0.001），反应率为25.2%。在完成减量期的110名患者中，从基线的平均降低率为42.6%（p < 0.001），反应率和缓解率分别为49.6%和34.8%。在符合复发预防期条件的61名患者中，43名完成了该阶段，从基线的平均降低率为60.1%（p < 0.001）；7名患者在此阶段复发。这项研究表明，延长的aiTBS方案安全地为重度抑郁症患者带来了有意义的临床结果，这些患者原本会接受ECT治疗，从而在大流行期间减轻了ECT服务的压力。试验注册：ClinicalTrials.gov标识符：NCT04384965（https://clinicaltrials.gov/study/NCT04384965?term=NCT04384965&rank=1）。
