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Baseline characteristics of a European patient population with difficult-to-treat depression (RESTORE-LIFE) treated with adjunctive vagus nerve stimulation

Lookup NU author(s): Dr Tiago Costa, Beth Hall, Professor Hamish McAllister-WilliamsORCiD, Professor Allan Young



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2023 The Authors. 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.

Publication metadata

Author(s): Demyttenaere K, Costa T, Kavakbasi E, Jiang M, Scheltens A, Dibue M, Hall BE, Andrade P, McAllister-Williams RH, Baune BT, Young AH

Publication type: Article

Publication status: Published

Journal: Journal of Affective Disorders

Year: 2024

Volume: 344

Pages: 284-291

Print publication date: 01/01/2024

Online publication date: 12/10/2023

Acceptance date: 08/10/2023

Date deposited: 24/10/2023

ISSN (print): 0165-0327

ISSN (electronic): 1573-2517

Publisher: Elsevier BV


DOI: 10.1016/j.jad.2023.10.054

PubMed id: 37838271


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