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

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    Abstract

    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
    Volume38
    Issue number5
    DOIs
    Publication statusPublished - May 2008

    Keywords

    • brain stimulation
    • major depression
    • treatment resistance
    • vagus nerve stimulation
    • TREATMENT-RESISTANT DEPRESSION
    • CEREBRAL-BLOOD-FLOW
    • MAJOR DEPRESSION
    • LONG-TERM
    • THERAPY
    • EPILEPSY
    • SEIZURES
    • MECHANISMS
    • PLACEBO
    • TRIAL

    Cite this

    Schlaepfer, T. E., Frick, C., Zobel, A., Maier, W., Heuser, I., Bajbouj, M., ... Hasdemir, M. (2008). Vagus nerve stimulation for depression: efficacy and safety in a European study. Psychological Medicine, 38(5), 651-661. https://doi.org/10.1017/S0033291707001924
    Schlaepfer, T. E. ; Frick, C. ; Zobel, A. ; Maier, W. ; Heuser, I. ; Bajbouj, M. ; O'Keane, V. ; Corcoran, C. ; Adolfsson, R. ; Trimble, M. ; Rau, H. ; Hoff, H. -J. ; Padberg, F. ; Mueller-Siecheneder, F. ; Audenaert, K. ; Van den Abbeele, D. ; Matthews, K. ; Christmas, D. ; Stanga, Z. ; Hasdemir, M. / Vagus nerve stimulation for depression: efficacy and safety in a European study. In: Psychological Medicine. 2008 ; Vol. 38, No. 5. pp. 651-661.
    @article{6cec235bbd0b4ee589dcb03bbb51b012,
    title = "Vagus nerve stimulation for depression: efficacy and safety in a European study",
    abstract = "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.",
    keywords = "brain stimulation, major depression, treatment resistance, vagus nerve stimulation, TREATMENT-RESISTANT DEPRESSION, CEREBRAL-BLOOD-FLOW, MAJOR DEPRESSION, LONG-TERM, THERAPY, EPILEPSY, SEIZURES, MECHANISMS, PLACEBO, TRIAL",
    author = "Schlaepfer, {T. E.} and C. Frick and A. Zobel and W. Maier and I. Heuser and M. Bajbouj and V. O'Keane and C. Corcoran and R. Adolfsson and M. Trimble and H. Rau and Hoff, {H. -J.} and F. Padberg and F. Mueller-Siecheneder and K. Audenaert and {Van den Abbeele}, D. and K. Matthews and D. Christmas and Z. Stanga and M. Hasdemir",
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    Schlaepfer, TE, Frick, C, Zobel, A, Maier, W, Heuser, I, Bajbouj, M, O'Keane, V, Corcoran, C, Adolfsson, R, Trimble, M, Rau, H, Hoff, H-J, Padberg, F, Mueller-Siecheneder, F, Audenaert, K, Van den Abbeele, D, Matthews, K, Christmas, D, Stanga, Z & Hasdemir, M 2008, 'Vagus nerve stimulation for depression: efficacy and safety in a European study', Psychological Medicine, vol. 38, no. 5, pp. 651-661. https://doi.org/10.1017/S0033291707001924

    Vagus nerve stimulation for depression: efficacy and safety in a European study. / Schlaepfer, T. E.; Frick, C.; Zobel, A.; Maier, W.; Heuser, I.; Bajbouj, M.; O'Keane, V.; Corcoran, C.; Adolfsson, R.; Trimble, M.; Rau, H.; Hoff, H. -J.; Padberg, F.; Mueller-Siecheneder, F.; Audenaert, K.; Van den Abbeele, D.; Matthews, K.; Christmas, D.; Stanga, Z.; Hasdemir, M.

    In: Psychological Medicine, Vol. 38, No. 5, 05.2008, p. 651-661.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Vagus nerve stimulation for depression: efficacy and safety in a European study

    AU - Schlaepfer, T. E.

    AU - Frick, C.

    AU - Zobel, A.

    AU - Maier, W.

    AU - Heuser, I.

    AU - Bajbouj, M.

    AU - O'Keane, V.

    AU - Corcoran, C.

    AU - Adolfsson, R.

    AU - Trimble, M.

    AU - Rau, H.

    AU - Hoff, H. -J.

    AU - Padberg, F.

    AU - Mueller-Siecheneder, F.

    AU - Audenaert, K.

    AU - Van den Abbeele, D.

    AU - Matthews, K.

    AU - Christmas, D.

    AU - Stanga, Z.

    AU - Hasdemir, M.

    PY - 2008/5

    Y1 - 2008/5

    N2 - 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.

    AB - 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.

    KW - brain stimulation

    KW - major depression

    KW - treatment resistance

    KW - vagus nerve stimulation

    KW - TREATMENT-RESISTANT DEPRESSION

    KW - CEREBRAL-BLOOD-FLOW

    KW - MAJOR DEPRESSION

    KW - LONG-TERM

    KW - THERAPY

    KW - EPILEPSY

    KW - SEIZURES

    KW - MECHANISMS

    KW - PLACEBO

    KW - TRIAL

    U2 - 10.1017/S0033291707001924

    DO - 10.1017/S0033291707001924

    M3 - Article

    VL - 38

    SP - 651

    EP - 661

    JO - Psychological Medicine

    JF - Psychological Medicine

    SN - 0033-2917

    IS - 5

    ER -

    Schlaepfer TE, Frick C, Zobel A, Maier W, Heuser I, Bajbouj M et al. Vagus nerve stimulation for depression: efficacy and safety in a European study. Psychological Medicine. 2008 May;38(5):651-661. https://doi.org/10.1017/S0033291707001924