Related Experiment Video
Updated: Jul 13, 2025
Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression
Published on: January 7, 2019
Baseline characteristics of a European patient population with difficult-to-treat depression (RESTORE-LIFE) treated
Koen Demyttenaere1, Tiago Costa2, Erhan Kavakbasi3
1University Psychiatric Centre, KU Leuven, Leuven, Belgium.
Background:
Major depressive disorder is a complex heterogeneous disorder. Treatment is especially challenging for patients with "difficult-to-treat depression" (DTD): a less stigmatizing and more clinically relevant framework defining depression that continues to cause significant burden despite usual treatment efforts.
Methods:
RESTORE-LIFE is a prospective, observational, multicenter, post-market study being conducted in Europe and is designed to reflect real-world clinical application of adjunctive Vagus Nerve Stimulation Therapy (VNS) for DTD. Baseline characteristics of RESTORE-LIFE patients were analyzed and compared to published treatment-resistant depression (TRD) trials.
Results:
This analysis includes the initial 98 RESTORE-LIFE patients who commenced treatment with VNS. Patients had a mean of 11.4 failed anti-depressant treatments, 1.1 suicide attempts, 87 % had prior electroconvulsive therapy, and 36 % had an endocrine/metabolic comorbidity. On average, disease severity was comparable to that in TRD trials (n = 15,463). However, RESTORE-LIFE patients appear to have been experiencing DTD for a longer duration and their DTD was characterized by a lack of positive mental health and meaningfulness of life, to a greater degree than by excess of negative mood. Despite high comorbidity rates in RESTORE-LIFE, VNS implantation was performed safely with no discontinuations due to surgical adverse events.
Limitations:
RESTORE-LIFE enrolls any patient receiving adjunctive VNS for DTD. Prescription of VNS may be biased by differences in practices amongst sites and countries.
Conclusions:
The present analysis offers insight into contemporary real-world use of VNS Therapy for DTD in Europe representing a comprehensive characterization of DTD and how this population may differ from those in the TRD literature.
