Two-Year Outcome of Vagus Nerve Stimulation in Treatment-Resistant Depression

Malek Bajbouj, Angela Merkl, Thomas E. Schlaepfer, Caroline Frick, Astrid Zobel, Wolfgang Maier, Veronica O'Keane, Ciaran Corcoran, Rolf Adolfsson, Michael Trimble, Harald Rau, Hans-Joachim Hoff, Frank Padberg, Florian Mueller-Siecheneder, Kurt Audenaert, Dirk van den Abbeele, Keith Matthews, David Christmas, Sam Eljamel, Isabella Heuser

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    126 Citations (Scopus)


    One of the major goals of antidepressant treatment is a sustained response and remission of depressive symptoms. Some of the previous studies of vagus nerve stimulation (VNS) have suggested antidepressant effects. Our naturalistic study assessed the efficacy and the safety of VNS in 74 European patients with therapy-resistant major depressive disorder. Psychometric measures were obtained after 3, 12, and 24 months of VNS. Mixed-model repeated-measures analysis of variance revealed a significant reduction (P <= 0.05) at all the 3 time points in the 28-item Hamilton Rating Scale for Depression (HRSD28) score, the primary outcome measure. After 2 years, 53.1% (26/49) of the patients fulfilled the response criteria (>= 50% reduction in the HRSD28 scores from baseline) and 38.9% (19/49) fulfilled the remission criteria (HRSD28 scores <= 10). The proportion of patients who fulfilled the remission criteria remained constant as the duration of VNS treatment increased. Voice alteration, cough, and pain were the most frequently reported adverse effects. Two patients committed suicide during the study; no other deaths were reported. No statistically significant differences were seen in the number of concomitant antidepressant medications. The results of this 2-year open-label trial suggest a clinical response and a comparatively benign adverse effect profile among patients with treatment-resistant depression.

    Original languageEnglish
    Pages (from-to)273-281
    Number of pages9
    JournalJournal of Clinical Psychopharmacology
    Issue number3
    Publication statusPublished - Jun 2010


    • clinical trial
    • Hamilton Rating Scale for Depression
    • major depressive disorder
    • depression
    • vagus nerve stimulation
    • IMPACT


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