TY - JOUR
T1 - Baseline characteristics of a European patient population with difficult-to-treat depression (RESTORE-LIFE) treated with adjunctive vagus nerve stimulation
AU - Demyttenaere, Koen
AU - Costa, Tiago
AU - Kavakbasi, Erhan
AU - Jiang, Mei
AU - Scheltens, An
AU - Dibué, Maxine
AU - Hall, Beth E
AU - Andrade, Pablo
AU - McAllister-Williams, R Hamish
AU - Baune, Bernhard T
AU - Young, Allan H
N1 - Funding Information:
The authors are grateful to the patients and their families who participated in the RESTORE-LIFE study. The authors also thank Karishma L. Manzur, PhD of Lenimen Consulting, LLC for providing medical writing assistance which was funded by LivaNova.
Funding Information:
This article reports the initial baseline results of a clinical study being funded by LivaNova, PLC, the developer and manufacturer of the Vagus Nerve Stimulation (VNS) Therapy system.
Publisher Copyright:
© 2023 The Authors
PY - 2024/1/1
Y1 - 2024/1/1
N2 - 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.
AB - 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.
KW - Humans
KW - Vagus Nerve Stimulation/adverse effects
KW - Depressive Disorder, Major/therapy
KW - Depression
KW - Prospective Studies
KW - Treatment Outcome
KW - Vagus Nerve/physiology
UR - http://www.scopus.com/inward/record.url?scp=85174061959&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2023.10.054
DO - 10.1016/j.jad.2023.10.054
M3 - Article
C2 - 37838271
SN - 0165-0327
VL - 344
SP - 284
EP - 291
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
ER -
