Background

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).

Methods

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.

Results

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.

Limitations

This was a single-arm, open-label study, and enrollment was limited to participants with mild-to-moderate peripartum depression.

Conclusion

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. ClinicalTrials.gov NCT03972995

中文翻译：

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经皮耳迷走神经刺激对围产期发作的重度抑郁症的影响：一项多中心、开放标签、受控概念验证临床试验 (DELOS-1)

背景

产后抑郁症在美国的患病率很高（约 13 %），而且常常得不到充分治疗/未得到治疗。我们进行了一项多中心、开放标签、概念验证试验，以评估 Nēsos 可穿戴、非侵入性、经皮耳廓迷走神经刺激 (taVNS) 系统用于治疗围产期发作 (PPD) 的重度抑郁症。

方法

在 3 个地点招募了 18 至 45 岁、产后 9 个月内被诊断患有 PPD 的女性 (n = 25)。该研究包括 6 周的开放标签治疗和 2 周的观察。疗效结果包括汉密尔顿抑郁评定量表 (HAM D17) 总分、HAM-D17 反应和缓解以及患者和临床医生对变化的整体印象 (PGIC、CGIC) 评分与基线 (CFB) 的变化。分析包括重复测量的描述性统计和混合效应模型。

结果

最常见的 AE (≥5 %) 是不适 (n = 5)、头痛 (n = 3) 和头晕 (n = 2)；无需干预即可全部解决。没有发生严重的 AE 或死亡。基线平均 HAM-D17 评分为 18.4。HAM-D17 评分中的第 6 周最小二乘 (LS) 平均 CFB 为 -9.7；74 % 获得缓解，61 % 获得缓解。在第 6 周，CGIC 的 22 名临床医生中的 21 名 (95%) 和 PGIC 的 23 名参与者中的 22 名 (96%) 报告了至少一些改善。

限制

这是一项单臂、开放标签研究，仅限于患有轻度至中度围产期抑郁症的参与者。

结论

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，并且可能是围产期发作的重度抑郁症的一种有效的非侵入性、非药物治疗。需要在更大的假对照研究中进行进一步评估。ClinicalTrials.gov NCT03972995