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

Malek Bajbouj, Angela Merkl, Thomas E Schlaepfer, Caroline Frick, Astrid Zobel, Wolfgang Maier, Veronica O'Keane, Ciaran Corcoran, Rolf Adolfsson and Michael Trimble, et al. (2010) JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY. 30(3). p.273-281
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.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
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
journal title
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
J. Clin. Psychopharmacol.
volume
30
issue
3
pages
273 - 281
Web of Science type
Article
Web of Science id
000277680400009
JCR category
PHARMACOLOGY & PHARMACY
JCR impact factor
4.857 (2010)
JCR rank
21/249 (2010)
JCR quartile
1 (2010)
ISSN
0271-0749
DOI
10.1097/JCP.0b013e3181db8831
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1063510
handle
http://hdl.handle.net/1854/LU-1063510
date created
2010-10-25 15:11:30
date last changed
2011-07-01 00:30:24
@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},
}

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.