Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder with peripartum onset: A multicenter, open-label, controlled proof-of-concept clinical trial (DELOS-1)

Kristina M. Deligiannidis, Thalia Robakis, Sarah C. Homitsky, Erona Ibroci, Bridget King, Sunu Jacob, Diana Coppola, Shane Raines, Konstantinos Alataris

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

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 (HAM[sbnd]D17) 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

Original languageEnglish
Pages (from-to)34-41
Number of pages8
JournalJournal of Affective Disorders
Volume316
DOIs
StatePublished - 1 Nov 2022

Keywords

  • Antidepressant
  • Neuromodulation
  • Peripartum depression
  • Postpartum
  • Vagus nerve stimulation

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