Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial

Summary & key facts

This 12-month, randomized, sham-controlled trial tested vagus nerve stimulation (VNS) as an add-on treatment in 493 adults with marked treatment-resistant major depression. The main outcome—percent time in response on the MADRS from months 3–12—did not differ between active and sham VNS. However, several other measures filled out by clinicians, patients, and masked raters showed that active VNS gave more time in response or partial response. VNS caused more shortness of breath (dyspnea) but no new safety problems were identified. The authors conclude VNS was safe and had antidepressant effects on multiple measures in people with marked TRD.

Key facts:

• 493 adults with marked treatment-resistant major depression were randomized to active VNS or no-stimulation sham VNS for 12 months.
• 88.4% of participants completed the one-year trial.
• The primary outcome—percent time in response on the MADRS across months 3–12—did not differ between active and sham VNS.
• Active VNS showed significantly more percent time in response on the on-site clinician rating (CGI-I) with P = 0.004.
• Active VNS also showed significantly more percent time in response on the patient self-report (QIDS-SR) with P = 0.049.
• Active VNS produced significantly more percent time in partial response (≥30% symptom improvement) on the CGI-I (P < 0.001) and on offsite masked rater QIDS-C (P = 0.006).
• Active VNS had a higher rate of dyspnea (shortness of breath) than sham (P = 0.035); no new adverse events were reported.

Abstract

Percent time in MADRS response did not distinguish the treatment groups, but on multiple instruments time in response and PR showed a positive treatment effect. VNS was found safe and effective in participants with marked TRD.

Topics

Heart Rate Variability and Autonomic Control Neurological disorders and treatments Vagus Nerve Stimulation Research

Categories

Life Sciences Neurology Neuroscience

Tags

Anesthesia Depression (economics) Economics Internal medicine Macroeconomics Medicine Randomized controlled trial Stimulation Vagus nerve Vagus nerve stimulation

Conditions & symptoms

Depression Lack of energy or motivation Sadness or low mood