title: Two-year outcome of vagus nerve stimulation in treatment-resistant depression.
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 < or = 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 (> or =50% reduction in the HRSD28 scores from baseline) and 38.9% (19/49) fulfilled the remission criteria (HRSD28 scores < or = 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.
authors.affiliation: Department of Psychiatry, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany. malek.bajbouj@charite.de
authors.forename: Malek
authors.initials: M
authors.lastname: Bajbouj
authors.forename: Angela
authors.initials: A
authors.lastname: Merkl
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Schlaepfer
authors.forename: Caroline
authors.initials: C
authors.lastname: Frick
authors.forename: Astrid
authors.initials: A
authors.lastname: Zobel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Maier
authors.forename: Veronica
authors.initials: V
authors.lastname: O'Keane
authors.forename: Ciaran
authors.initials: C
authors.lastname: Corcoran
authors.forename: Rolf
authors.initials: R
authors.lastname: Adolfsson
authors.forename: Michael
authors.initials: M
authors.lastname: Trimble
authors.forename: Harald
authors.initials: H
authors.lastname: Rau
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Hoff
authors.forename: Frank
authors.initials: F
authors.lastname: Padberg
authors.forename: Florian
authors.initials: F
authors.lastname: Müller-Siecheneder
authors.forename: Kurt
authors.initials: K
authors.lastname: Audenaert
authors.forename: Dirk
authors.initials: D
authors.lastname: van den Abbeele
authors.forename: Keith
authors.initials: K
authors.lastname: Matthews
authors.forename: David
authors.initials: D
authors.lastname: Christmas
authors.forename: Sam
authors.initials: S
authors.lastname: Eljamel
authors.forename: Isabella
authors.initials: I
authors.lastname: Heuser
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003865:Major Depressive Disorder / Q000523:psychology* / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*; D055815:Young Adult