title: A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality.
abstract: The Treatment-Resistant Depression Registry investigated whether adjunctive vagus nerve stimulation (VNS) with treatment as usual in depression has superior long-term outcomes compared with treatment as usual only.
  
  
  
  This 5-year, prospective, open-label, nonrandomized, observational registry study was conducted at 61 U.S. sites and included 795 patients who were experiencing a major depressive episode (unipolar or bipolar depression) of at least 2 years' duration or had three or more depressive episodes (including the current episode), and who had failed four or more depression treatments (including ECT). Patients with a history of psychosis or rapid-cycling bipolar disorder were excluded. The primary efficacy measure was response rate, defined as a decrease of ≥50% in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score at any postbaseline visit during the 5-year study. Secondary efficacy measures included remission.
  
  
  
  Patients had chronic moderate to severe depression at baseline (the mean MADRS score was 29.3 [SD=6.9] for the treatment-as-usual group and 33.1 [SD=7.0] for the adjunctive VNS group). The registry results indicate that the adjunctive VNS group had better clinical outcomes than the treatment-as-usual group, including a significantly higher 5-year cumulative response rate (67.6% compared with 40.9%) and a significantly higher remission rate (cumulative first-time remitters, 43.3% compared with 25.7%). A subanalysis demonstrated that among patients with a history of response to ECT, those in the adjunctive VNS group had a significantly higher 5-year cumulative response rate than those in the treatment-as-usual group (71.3% compared with 56.9%). A similar significant response differential was observed among ECT nonresponders (59.6% compared with 34.1%).
  
  
  
  This registry represents the longest and largest naturalistic study of efficacy outcomes in treatment-resistant depression, and it provides additional evidence that adjunctive VNS has enhanced antidepressant effects compared with treatment as usual in this severely ill patient population.
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Aaronson
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Peter
authors.initials: P
authors.lastname: Sears
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Francis
authors.initials: F
authors.lastname: Ruvuna
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Mark
authors.initials: M
authors.lastname: Bunker
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Charles R
authors.initials: CR
authors.lastname: Conway
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Darin D
authors.initials: DD
authors.lastname: Dougherty
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Frederick W
authors.initials: FW
authors.lastname: Reimherr
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Schwartz
authors.affiliation: From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago.
authors.forename: John M
authors.initials: JM
authors.lastname: Zajecka
mesh_terms: D000328:Adult; D001714:Bipolar Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002908:Chronic Disease; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D061218:Depressive Disorder, Treatment-Resistant / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004565:Electroconvulsive Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D059020:Suicidal Ideation; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*
keywords: Mortality; Remission; Response; Suicidality; Treatment-Resistant Depression; Vagus Nerve Stimulation