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Two-year outcome of vagus nerve stimulation in treatment-resistant depression

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Abstract
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.
Keywords
EPISODES, EFFICACY, SYMPTOMS, DRUG-THERAPY, PLACEBO, OUTPATIENTS, ELECTROCONVULSIVE-THERAPY, CLINICAL-TRIALS, major depressive disorder, clinical trial, depression, vagus nerve stimulation, Hamilton Rating Scale for Depression, IMPROVE, IMPACT

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Chicago
Bajbouj, Malek, Angela Merkl, Thomas E Schlaepfer, Caroline Frick, Astrid Zobel, Wolfgang Maier, Veronica O’Keane, et al. 2010. “Two-year Outcome of Vagus Nerve Stimulation in Treatment-resistant Depression.” Journal of Clinical Psychopharmacology 30 (3): 273–281.
APA
Bajbouj, M., Merkl, A., Schlaepfer, T. E., Frick, C., Zobel, A., Maier, W., O’Keane, V., et al. (2010). Two-year outcome of vagus nerve stimulation in treatment-resistant depression. JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, 30(3), 273–281.
Vancouver
1.
Bajbouj M, Merkl A, Schlaepfer TE, Frick C, Zobel A, Maier W, et al. Two-year outcome of vagus nerve stimulation in treatment-resistant depression. JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY. 2010;30(3):273–81.
MLA
Bajbouj, Malek, Angela Merkl, Thomas E Schlaepfer, et al. “Two-year Outcome of Vagus Nerve Stimulation in Treatment-resistant Depression.” JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY 30.3 (2010): 273–281. Print.
@article{1063510,
  abstract     = {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 {\textlangle}= 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 ({\textrangle}= 50\% reduction in the HRSD28 scores from baseline) and 38.9\% (19/49) fulfilled the remission criteria (HRSD28 scores {\textlangle}= 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.},
  author       = {Bajbouj, Malek and Merkl, Angela and Schlaepfer, Thomas E and Frick, Caroline and Zobel, Astrid and Maier, Wolfgang and O'Keane, Veronica and Corcoran, Ciaran and Adolfsson, Rolf and Trimble, Michael and Rau, Harald and Hoff, Hans-Joachim and Padberg, Frank and Muller-Siecheneder, Florian and Audenaert, Kurt and Van den Abeele, Dirk and Matthews, Keith and Christmas, David and Eljamel, Sam and Heuser, Isabella},
  issn         = {0271-0749},
  journal      = {JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY},
  keyword      = {EPISODES,EFFICACY,SYMPTOMS,DRUG-THERAPY,PLACEBO,OUTPATIENTS,ELECTROCONVULSIVE-THERAPY,CLINICAL-TRIALS,major depressive disorder,clinical trial,depression,vagus nerve stimulation,Hamilton Rating Scale for Depression,IMPROVE,IMPACT},
  language     = {eng},
  number       = {3},
  pages        = {273--281},
  title        = {Two-year outcome of vagus nerve stimulation in treatment-resistant depression},
  url          = {http://dx.doi.org/10.1097/JCP.0b013e3181db8831},
  volume       = {30},
  year         = {2010},
}

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