Vagus nerve stimulation for depression: efficacy and safety in a European study

T. E. Schlaepfer, C. Frick, A. Zobel, W. Maier, I. Heuser, M. Bajbouj, V. O'Keane, C. Corcoran, R. Adolfsson, M. Trimble, H. Rau, H. -J. Hoff, F. Padberg, F. Mueller-Siecheneder, K. Audenaert, D. Van den Abbeele, K. Matthews, D. Christmas, Z. Stanga, M. Hasdemir

    Research output: Contribution to journalArticlepeer-review

    165 Citations (Scopus)


    Background. Vagus nerve stimulation (VNS) therapy is associated with a decrease in seizure frequency in partial-onset seizure patients. Initial trials suggest that it may be an effective treatment, with few side-effects, for intractable depression.

    Method. An open, uncontrolled European multi-centre study (D03) of VNS therapy was conducted, in addition to stable pharmacotherapy, in 74 patients with treatment-resistant depression (TRD). Treatment remained unchanged for the first 3 months; in the subsequent 9 months, medications and VNS dosing parameters were altered as indicated clinically.

    Results. The baseline 28-item Hamilton Depression Rating Scale (HAMD-28) score averaged 34. After 3 months of VNS, response rates (>= 50% reduction in baseline scores) reached 37% and remission rates (HAMD-28 score <10) 17%. Response rates increased to 53% after 1 year of VNS, and remission rates reached 33%. Response was defined as sustained if no relapse occurred during the first year of VNS after response onset; 44% of patients met these criteria. Median time to response was 9 months. Most frequent side-effects were voice alteration (63% at 3 months of stimulation) and coughing (23 %).

    Conclusions. VNS therapy was effective in reducing severity of depression; efficacy increased over time. Efficacy ratings were in the same range as those previously reported from a USA study using a similar protocol; at 12 months, reduction of symptom severity was significantly higher in the European sample. This might be explained by a small but significant difference in the baseline HAMD-28 score and the lower number of treatments in the current episode in the European study.

    Original languageEnglish
    Pages (from-to)651-661
    Number of pages11
    JournalPsychological Medicine
    Issue number5
    Publication statusPublished - May 2008


    • brain stimulation
    • major depression
    • treatment resistance
    • vagus nerve stimulation
    • TRIAL


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