Yang Sichang, Qin Zongshi, Yang Xinjing, Chan Mei Yan, Zhang Shuiyan, Rong Peijing, Hou Xiaobing, Jin Guixing, Xu Fengquan, Liu Yong, Zhang Zhang-Jin
Department of Chinese Medicine, The University of Hong Kong Shenzhen Hospital (HKU-SZH), Shenzhen, China.
LKS Faculty of Medicine, School of Chinese Medicine, The University of Hong Kong, Pokfulam, Hong Kong SAR, China.
Front Psychiatry. 2022 May 10;13:829932. doi: 10.3389/fpsyt.2022.829932. eCollection 2022.
Previous studies in animals and humans indicated that transcutaneous vagus nerve stimulation (tVNS) and transcutaneous electrical acupoint stimulation (TEAS) on trigeminal nerve-innervated forehead acupoints can relief the symptoms of depression. However, due to the limited investigations on these two interventions, more research are needed to confirm their efficacy in depression. To improve the efficacy of the single treatment, we combined two treatments and created a novel non-invasive stimulation, transcutaneous electrical cranial-auricular acupoint stimulation (TECAS). To assess the efficacy and safety of TECAS, we compare it with a selective serotonin reuptake inhibitor (SSRI), escitalopram, for the treatment of depression.
METHODS/DESIGN: This is a multi-center, non-inferiority, randomized controlled trial that will involve 470 patients with mild to moderate depression. Patients will be randomly assigned to either the TECAS group or the escitalopram group in a 1:1 ratio. The TEAS group will receive two sessions of treatments per day for 8 consecutive weeks, and the escitalopram group will receive 8 weeks of oral escitalopram tablets prescribed by clinical psychiatrists as appropriate for their condition. The primary outcome is the clinical response as determined by Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week 8, with -10% as the non-inferior margin. The secondary outcomes include the response rate determined by 17-item Hamilton Depression Rating Scale (HAMD-17), remission rate, changes from baseline in the scores on the MADRS, the HAMD-17, the Hamilton Anxiety Rating Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), and the Short Form 36 Health Survey (SF-36).
This will be the first randomized controlled trial to compare the efficacy of TECAS with escitalopram for depression. If effective, this novel intervention could have significant clinical and research implications for patients with depression.
[ClinicalTrials.gov], identifier [NCT03909217].
先前在动物和人类中的研究表明，经皮迷走神经刺激（tVNS）和经皮电刺激三叉神经支配的前额穴位（TEAS）可缓解抑郁症状。然而，由于对这两种干预措施的研究有限，需要更多研究来证实它们在抑郁症中的疗效。为了提高单一治疗的疗效，我们将两种治疗方法结合起来，创造了一种新的非侵入性刺激方法，即经皮颅耳穴位电刺激（TECAS）。为了评估TECAS的疗效和安全性，我们将其与选择性5-羟色胺再摄取抑制剂（SSRI）艾司西酞普兰进行比较，用于治疗抑郁症。
方法/设计：这是一项多中心、非劣效性、随机对照试验，将纳入470例轻度至中度抑郁症患者。患者将按1:1的比例随机分配到TECAS组或艾司西酞普兰组。TECAS组将连续8周每天接受两次治疗，艾司西酞普兰组将接受临床精神科医生根据其病情开具的8周口服艾司西酞普兰片治疗。主要结局是第8周时由蒙哥马利-Åsberg抑郁评定量表（MADRS）评分确定的临床反应，非劣效界值为-10%。次要结局包括由17项汉密尔顿抑郁评定量表（HAMD-17）确定的缓解率、缓解率、MADRS、HAMD-17、汉密尔顿焦虑评定量表（HAMA）、匹兹堡睡眠质量指数（PSQI）和简明健康调查36项量表（SF-36）得分相对于基线的变化。
这将是第一项比较TECAS与艾司西酞普兰治疗抑郁症疗效的随机对照试验。如果有效，这种新的干预措施可能对抑郁症患者具有重大的临床和研究意义。
[ClinicalTrials.gov]，标识符[NCT03909217]。
