A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
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OBJECTIVE: To compare response and remission rates in depressed patients with chronic treatment-resistant depression (TRD) treated with vagus nerve stimulation (VNS) Therapy(®) plus treatment as usual (VNS + TAU) or TAU alone in a meta-analysis using Bayesian hierarchical models. DATA SOURCES AND STUDY SELECTION: Six outpatient, multicenter, clinical trials that have evaluated VNS + TAU or TAU in TRD, including two single-arm studies of VNS + TAU (n = 60 and n = 74), a randomized study of VNS + TAU versus TAU (n = 235), a randomized study of VNS + TAU comparing different VNS stimulation intensities (n = 331), a nonrandomized registry of VNS + TAU versus TAU (n = 636), and a single-arm study of TAU (n = 124) to provide longer-term, control data for comparison with VNS-treated patients. DATA EXTRACTION: A systematic review of individual patient-level data based on the intent-to-treat principle, including all patients who contributed more than one post-baseline visit. Response was based on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impressions scale's Improvement subscale (CGI-I), as these were the two clinician-rated measures common across all or most studies. Remission was based on the MADRS. RESULTS: Outcomes were compared from baseline up to 96 weeks of treatment with VNS + TAU (n = 1035) versus TAU (n = 425). The MADRS response rate for VNS + TAU at 12, 24, 48, and 96 weeks were 12%, 18%, 28%, and 32% versus 4%, 7%, 12%, and 14% for TAU. The MADRS remission rate for VNS + TAU at 12, 24, 48, and 96 weeks were 3%, 5%, 10%, and 14% versus 1%, 1%, 2%, and 4%, for TAU. Adjunctive VNS Therapy was associated with a greater likelihood of response (odds ratio [OR] = 3.19, 95% confidence interval [CI]: 2.12, 4.66) and remission (OR = 4.99, CI: 2.93, 7.76), compared with TAU. For patients who had responded to VNS + TAU at 24 weeks, sustained response was more likely at 48 weeks (OR = 1.98, CI: 1.34, 3.01) and at 96 weeks (OR = 3.42, CI: 1.78, 7.31). Similar results were observed for CGI-I response. CONCLUSION: For patients with chronic TRD, VNS + TAU has greater response and remission rates that are more likely to persist than TAU.
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A meta-analysis that compared the application of VNS to the usual treatment in depressed patients showed a response rate of approximately 50% in the acute phase of the disease and a long-term remission rate of 20% after 2 years of treatment.
“A meta analysis that compared the application of VNS to the usual treatment in depressed patients showed a response rate of approximately 50% in the acute phase of the disease and a long-term remission rate of 20% after 2 years of treatment (114).”
From Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders (2018) · cites this paper as [114]
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- Authors
- Olin, B., Berry, Broglio, Bunker, Jayewardene, & Rush
- Affiliations
- Berry Consultants, LLC (United States) (US)
- Corresponding author
- Olin, Bryan
- Venue
- Medical Devices: Evidence and Research
- Publisher
- Informa UK Limited
- Published
- 2013-03
- Volume
- 6
- Pages
- 17
- ISSN
- 1179-1470 (ISSN-L)
- PMC
- PMC3590011
- OpenAlex
- W1953956911
- Cited by
- 152
- References
- 45
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 20 · 2023: 8 · 2022: 11 · 2021: 17 · 2020: 19 · 2019: 10 · 2018: 9 · 2017: 13 · 2016: 12 · 2015: 16 · 2014: 8 · 2013: 1
- FWCI
- 1.20
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Medical Devices Evidence and Research (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- vagus nerve stimulation, treatment-resistant depression, adjunctive therapy, depression remission, usual care, stimulation intensity, Bayesian hierarchical model, individual patient data, long-term outcomes, Montgomery-Asberg Depression Rating Scale, CGI-I
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