Summary

• Across all phase 3 studies in the treatment-resistant depression clinical trial program, patients were prohibited from using concomitant somatic treatments that included electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation, or transcranial magnetic stimulation.¹
• A small real-world prospective study (except for 1 patient who was included retrospectively) evaluated the outcomes of add-on vagus nerve stimulation (VNS) and esketamine (intravenous or intranasal) in patients with difficult-to-treat depression (mean, 8.9 failed antidepressant trials in the current episode). Six patients were included in the analysis. There was a significant improvement in the mean Montgomery-Åsberg Depression Rating Scale total score from the baseline at the 12-month follow-up (30.9 vs 18.3). Additionally, the mean number of esketamine sessions per month decreased from 2.33 at 6 months to 1.14 at 9 months and 0.8 at 12 months, and the mean number of hospitalizations per month significantly decreased from before vs after VNS (0.17 vs 0.11). However, the study had several limitations, including a small sample size, a lack of information in terms of which patients received the different formulations of esketamine, and the absence of a control group.²

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 09 October 2024.