TY - JOUR
T1 - Two-year outcome of vagus nerve stimulation in treatment-resistant depression
AU - Bajbouj, Malek
AU - Merkl, Angela
AU - Schlaepfer, Thomas E.
AU - Frick, Caroline
AU - Zobel, Astrid
AU - Maier, Wolfgang
AU - O'Keane, Veronica
AU - Corcoran, Ciaran
AU - Adolfsson, Rolf
AU - Trimble, Michael
AU - Rau, Harald
AU - Hoff, Hans Joachim
AU - Padberg, Frank
AU - Müller-Siecheneder, Florian
AU - Audenaert, Kurt
AU - Van Den Abbeele, Dirk
AU - Matthews, Keith
AU - Christmas, David
AU - Eljamel, Sam
AU - Heuser, Isabella
PY - 2010/6
Y1 - 2010/6
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Depression
KW - Hamilton Rating Scale for Depression
KW - Major depressive disorder
KW - Vagus nerve stimulation
UR - http://www.scopus.com/inward/record.url?scp=77952330742&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77952330742&partnerID=8YFLogxK
U2 - 10.1097/JCP.0b013e3181db8831
DO - 10.1097/JCP.0b013e3181db8831
M3 - Article
C2 - 20473062
AN - SCOPUS:77952330742
SN - 0271-0749
VL - 30
SP - 273
EP - 281
JO - Journal of clinical psychopharmacology
JF - Journal of clinical psychopharmacology
IS - 3
ER -