title: Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study.
abstract: BACKGROUND
  The need for effective, long-term treatment for recurrent or chronic, treatment-resistant depression is well established.
  
  
  METHODS
  This naturalistic follow-up describes outpatients with nonpsychotic major depressive (n = 185) or bipolar (I or II) disorder, depressed phase (n = 20) who initially received 10 weeks of active (n = 110) or sham vagus nerve stimulation (VNS) (n = 95). The initial active group received another 9 months, while the initial sham group received 12 months of VNS. Participants received antidepressant treatments and VNS, both of which could be adjusted.
  
  
  RESULTS
  The primary analysis (repeated measures linear regression) revealed a significant reduction in 24-item Hamilton Rating Scale for Depression (HRSD(24)) scores (average improvement, .45 points [SE = .05] per month (p < .001). At exit, HRSD(24) response rate was 27.2% (55/202); remission rate (HRSD(24) < or = 9) was 15.8% (32/202). Montgomery Asberg Depression Rating Scale (28.2% [57/202]) and Clinical Global Impression-Improvement (34.0% [68/200]) showed similar response rates. Voice alteration, dyspnea, and neck pain were the most frequently reported adverse events.
  
  
  CONCLUSIONS
  These 1-year open trial data found VNS to be well tolerated, suggesting a potential long-term, growing benefit in treatment-resistant depression, albeit in the context of changes in depression treatments. Comparative long-term data are needed to determine whether these benefits can be attributed to VNS.
authors.affiliation: Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. John.Rush@UTSouthwestern.edu
authors.forename: A John
authors.initials: AJ
authors.lastname: Rush
authors.forename: Harold A
authors.initials: HA
authors.lastname: Sackeim
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Marangell
authors.forename: Mark S
authors.initials: MS
authors.lastname: George
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Brannan
authors.forename: Sonia M
authors.initials: SM
authors.lastname: Davis
authors.forename: Phil
authors.initials: P
authors.lastname: Lavori
authors.forename: Robert
authors.initials: R
authors.lastname: Howland
authors.forename: Mitchel A
authors.initials: MA
authors.lastname: Kling
authors.forename: Barry
authors.initials: B
authors.lastname: Rittberg
authors.forename: Linda
authors.initials: L
authors.lastname: Carpenter
authors.forename: Philip
authors.initials: P
authors.lastname: Ninan
authors.forename: Francisco
authors.initials: F
authors.lastname: Moreno
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwartz
authors.forename: Charles
authors.initials: C
authors.lastname: Conway
authors.forename: Michael
authors.initials: M
authors.lastname: Burke
authors.forename: John J
authors.initials: JJ
authors.lastname: Barry
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D003710:Demography; D003866:Depressive Disorder / Q000628:therapy*; D004351:Drug Resistance; D004599:Electric Stimulation Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome; D014630:Vagus Nerve / Q000502:physiology / Q000528:radiation effects*
chemical_list: D000928:Antidepressive Agents