Vagus nerve stimulation (VNS™) for treatment-resistant depression: efficacy, side effects, and predictors of outcome
Abstract
This open pilot study of vagus nerve stimulation (VNS) in 60 patients with treatment-resistant major depressive episodes (MDEs) aimed to: 1) define the response rate; 2) determine the profile of side effects; and, most importantly; 3) establish predictors of clinical outcome. Participants were outpatients with nonatypical, nonpsychotic, major depressive or bipolar disorder who had not responded to at least two medication trials from different antidepressant classes in the current MDE. While on stable medication regimens, the patients completed a baseline period followed by device implantation. A 2-week, single blind, recovery period (no stimulation) was followed by 10 weeks of VNS. Of 59 completers (one patient improved during the recovery period), the response rate was 30.5% for the primary HRSD(28) measure, 34.0% for the Montgomery-Asberg Depression Rating Scale (MADRAS), and 37.3% for the Clinical Global Impression-Improvement Score (CGI-I of 1 or 2). The most common side effect was voice alteration or hoarseness, 55.0% (33/60), which was generally mild and related to output current intensity. History of treatment resistance was predictive of VNS outcome. Patients who had never received ECT (lifetime) were 3.9 times more likely to respond. Of the 13 patients who had not responded to more than seven adequate antidepressant trials in the current MDE, none responded, compared to 39.1% of the remaining 46 patients (p =.0057). Thus, VNS appears to be most effective in patients with low to moderate, but not extreme, antidepressant resistance. Evidence concerning VNS' long-term therapeutic benefits and tolerability will be critical in determining its role in treatment-resistant depression.
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A pilot study that examined the application of VNS in 60 patients with treatment-resistant depressive disorder showed a significant clinical improvement in 30-37% of patients and a high tolerability.
“A pilot study that examined the application of VNS in 60 patients with treatment-resistant depressive disorder showed a significant clinical improvement in 30–37% of patients and a high tolerability (78).”
From Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders (2018) · cites this paper as [78]
Neurostimulation such as vagus nerve stimulation, deep brain stimulation, or electroconvulsive therapy carries a risk of infections and other potential side effects due to surgical implantation.
“Neurostimulation, such as vagus nerve stimulation (VNS), deep brain stimulation (DBS), or electroconvulsive therapy (ECT), has been recommended and is effective for treatment-resistant depression; however, these interventions also possess a certain risk of developing infections and other potential side effects due to surgical implantation.[6–8]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [6]
Neurostimulation such as vagus nerve stimulation, deep brain stimulation, or electroconvulsive therapy has been recommended and is effective for treatment-resistant depression.
“Neurostimulation, such as vagus nerve stimulation (VNS), deep brain stimulation (DBS), or electroconvulsive therapy (ECT), has been recommended and is effective for treatment-resistant depression; however, these interventions also possess a certain risk of developing infections and other potential side effects due to surgical implantation.[6–8]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [6]
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- Authors
- Sackeim, H.
- Venue
- Neuropsychopharmacology
- Published
- 2001-11
- Volume
- 25
- Issue
- 5
- Pages
- 713-728
- ISSN
- 0893-133X (ISSN-L)
- OpenAlex
- W2171565404
- Cited by
- 568
- References
- 46
- Citations by year
- 2026: 9 · 2025: 14 · 2024: 30 · 2023: 14 · 2022: 29 · 2021: 19 · 2020: 22 · 2019: 22 · 2018: 21 · 2017: 22 · 2016: 18 · 2015: 22 · 2014: 15 · 2013: 21 · 2012: 16
- FWCI
- 14.22
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neuropsychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- World Health Organization
- Medical University of South Carolina
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Keywords
- vagus nerve stimulation, treatment-resistant depression, major depressive episode, bipolar disorder, predictors of treatment response, antidepressant resistance, adverse effects, voice change, device implantation, response rate
- MeSH terms
- Adolescent, Adult, Aged, Bipolar Disorder, Depressive Disorder, Drug Resistance, Electroconvulsive Therapy, Electrodes, Implanted, Electric Stimulation Therapy, Female, Humans, Male, Middle Aged, Pilot Projects, Psychiatric Status Rating Scales, Quality of Life, Vagus Nerve, Treatment Outcome, Mood Disorders
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