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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 (o50 % 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.

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