The Zucker Hillside Hospital, Women's Behavioral Health, Northwell Health, Glen Oaks, NY, USA; Departments of Psychiatry, Molecular Medicine and Obstetrics & Gynecology at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; The Feinstein Institutes for Medical Research, Manhasset, NY, USA.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
J Affect Disord. 2022 Nov 1;316:34-41. doi: 10.1016/j.jad.2022.07.068. Epub 2022 Aug 4.
Postpartum depression has a high prevalence in the United States (~13 %) and often goes undertreated/untreated. We conducted a multicenter, open-label, proof-of-concept trial to assess the Nēsos wearable, non-invasive, transcutaneous auricular vagus nerve stimulation (taVNS) system for the treatment of major depressive disorder with peripartum onset (PPD).
Women (n = 25), ages 18 to 45, within 9 months postpartum, and diagnosed with PPD were enrolled at 3 sites. The study included 6 weeks open-label therapy and 2 weeks observation. Efficacy outcomes included change from baseline (CFB) in Hamilton Rating Scale for Depression (HAMD17) total scores, HAM-D17 response and remission, and patient and clinician global impression of change (PGIC, CGIC) scores. Analysis included descriptive statistics and mixed-effects models for repeated measures.
The most common AEs (≥5 %) were discomfort (n = 5), headache (n = 3), and dizziness (n = 2); all resolved without intervention. No serious AEs or deaths occurred. Baseline mean HAM-D17 score was 18.4. Week 6 least squares (LS) mean CFB in HAM-D17 score was -9.7; 74 % achieved response and 61 % achieved remission. At week 6, at least some improvement was reported by 21 of 22 (95 %) clinicians on CGIC and 22 of 23 (96 %) participants on PGIC.
This was a single-arm, open-label study, and enrollment was limited to participants with mild-to-moderate peripartum depression.
Results from this proof-of-concept study suggest that the Nēsos taVNS system is well tolerated and may be an effective non-invasive, non-pharmacological treatment for major depressive disorder with peripartum onset. Further evaluation in larger sham-controlled studies is needed.
govNCT03972995.
产后抑郁症在美国的发病率很高（约为 13%），且往往治疗不足/未得到治疗。我们进行了一项多中心、开放性、概念验证试验，以评估 Nēsos 可穿戴、非侵入性、经皮耳迷走神经刺激（taVNS）系统治疗产后发病的重度抑郁症（PPD）。
在 3 个地点招募了年龄在 18 至 45 岁、产后 9 个月内、被诊断为 PPD 的女性（n=25）。该研究包括 6 周的开放性治疗和 2 周的观察期。疗效结果包括汉密尔顿抑郁量表（HAMD17）总分的从基线（CFB）变化、HAMD17 反应和缓解率，以及患者和临床医生对变化的总体印象（PGIC、CGIC）评分。分析包括描述性统计和重复测量的混合效应模型。
最常见的不良事件（AE）（≥5%）为不适（n=5）、头痛（n=3）和头晕（n=2）；所有不良事件均无需干预即可自行缓解。没有发生严重的不良事件或死亡。基线时 HAMD17 的平均得分是 18.4。第 6 周最小二乘（LS）平均 CFB 在 HAMD17 评分中为-9.7；74%的患者达到了反应，61%的患者达到了缓解。第 6 周时，22 名（95%）临床医生中至少有 21 名根据 CGIC 报告至少有一些改善，23 名（96%）参与者根据 PGIC 报告至少有 22 名改善。
这是一项单臂、开放性研究，仅纳入了轻度至中度产后抑郁的参与者。
这项概念验证研究的结果表明，Nēsos taVNS 系统具有良好的耐受性，可能是一种治疗产后发病的重度抑郁症的有效、非侵入性、非药物治疗方法。需要在更大的假对照研究中进一步评估。
govNCT03972995。
