Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial.

IF 7.6 1区 医学 Q1 CLINICAL NEUROLOGY
A John Rush, Charles R Conway, Scott T Aaronson, Mark S George, Patricio Riva-Posse, David L Dunner, John Zajecka, Mark T Bunker, João Quevedo, Rebecca M Allen, Gustavo Alva, Heather Luing, Ziad Nahas, Lucian Manu, Jeffrey I Bennett, Brian J Mickey, Jonathan Becker, Yvette Sheline, Cristina Cusin, James W Murrough, Kevin Reeves, Peter B Rosenquist, Ying-Chieh Lisa Lee, Shannon Majewski, Jeffrey Way, Bryan Olin, Harold A Sackeim
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引用次数: 0

Abstract

Background: Depression treatments aim to minimize symptom burden and optimize quality of life (QoL) and psychosocial function.

Objective: Compare the effects of adjunctive versus sham vagus nerve stimulation (VNS) on QoL and function in markedly treatment-resistant depression (TRD).

Methods: In this multicenter, double-blind, sham-controlled trial, 493 adults with TRD and ≥4 adequate but unsuccessful antidepressant treatment trials (current episode) were randomized to active (n = 249) or sham (n = 244) VNS (plus treatment as usual) over a 12-month observation period. Quarterly outcomes included QoL with the Q-LES-Q, Mini-Q-LES-Q, and EQ-5D-5L, and function with the WHODAS 2.0 and Work Productivity and Activity Impairment Questionnaire (WPAI) item 6. Differences between treatment groups in change in scores from baseline and percentage of time with a meaningful response in Q-LES-Q, Mini-Q-LES-Q, and WPAI item 6 scores were analyzed.

Results: Active VNS was superior to sham in mean change in scores from baseline in the Mini-Q-LES-Q (P = 0.050) and WPAI item 6 (health condition's effect on regular activities [P = 0.050]) used as continuous variables, with a similar trend for Q-LES-Q (P = 0.061). Active VNS was superior to sham in time spent in clinically meaningful benefit (categorical analyses) using the Q-LES-Q (P = 0.029), Mini-Q-LES-Q (P = 0.011), and WPAI item 6 (P = 0.039). The WHODAS 2.0 (P = 0.304) and EQ-5D visual analog scale (P = 0.125) failed to reveal between-group differences.

Conclusion: Active VNS was superior to sham VNS in improving QoL and psychosocial function in patients with TRD. VNS has a broader therapeutic impact than symptom improvement alone in patients with marked psychosocial impairment.

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来源期刊
Brain Stimulation
Brain Stimulation 医学-临床神经学
CiteScore
13.10
自引率
9.10%
发文量
256
审稿时长
72 days
期刊介绍: Brain Stimulation publishes on the entire field of brain stimulation, including noninvasive and invasive techniques and technologies that alter brain function through the use of electrical, magnetic, radiowave, or focally targeted pharmacologic stimulation. Brain Stimulation aims to be the premier journal for publication of original research in the field of neuromodulation. The journal includes: a) Original articles; b) Short Communications; c) Invited and original reviews; d) Technology and methodological perspectives (reviews of new devices, description of new methods, etc.); and e) Letters to the Editor. Special issues of the journal will be considered based on scientific merit.
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