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. Müller-Siecheneder, K. Audenaert, D. Van Den Abbeele, K. Matthews, D. Christmas, Z. Stanga, M. Hasdemir

Research output: Contribution to journalArticlepeer-review


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 (US)
Pages (from-to)651-661
Number of pages11
JournalPsychological medicine
Issue number5
StatePublished - May 2008
Externally publishedYes


  • Brain stimulation
  • Major depression
  • Treatment resistance
  • Vagus nerve

ASJC Scopus subject areas

  • Applied Psychology
  • Psychiatry and Mental health


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