TY - JOUR
T1 - A 5-year observational study of patients with treatment-resistant depression treated with vagus nerve stimulation or treatment as usual
T2 - Comparison of response, remission, and suicidality
AU - Aaronson, Scott T.
AU - Sears, Peter
AU - Ruvuna, Francis
AU - Bunker, Mark
AU - Conway, Charles R.
AU - Dougherty, Darin D.
AU - Reimherr, Frederick W.
AU - Schwartz, Thomas L.
AU - Zajecka, John M.
N1 - Funding Information:
Dr. Aaronson has served as a consultant or adviser for Genomind, LivaNova, Neuronetics, and Otsuka and as a speaker for Lundbeck, Neuronetics, Otsuka, Sunovion, and Takeda; he has received research support from Neuronetics, the Dalio Foundation, and the Stanley Medical Research Institute. Mr. Sears, Dr. Ruvuna, and Dr. Bunker are employees or former employees of Cyberonics (LivaNova), and Drs. Ruvuna and Bunker are stockholders. Dr. Conway has served as an unpaid consultant to Cyberonics and as a speaker for Bristol-Myers Squibb and Otsuka; he has received grant funding from the August Busch IV Foundation, the Barnes-Jewish Hospital Foundation, the Brain and Behavior Research Foundation (formerly NARSAD), Bristol-Myers Squibb (investigator-initiated neuro-imaging trial), NeoSync, NIMH, the Sidney R. Baer, Jr., Foundation, the Stanley Foundation, the Taylor Family Institute for Innovative Psychiatric Research, and the Washington University Center for Brain Research in Mood Disorders, and heisa part-time employee of the U.S. Department of Veterans Affairs. Dr. Dougherty has received research support from Cyberonics, Eli Lilly, Forest Laboratories, Medtronic, and Roche, consulting fees from Medtronic, travel support from Roche, and honoraria from Insys Therapeutics, Johnson & Johnson, and Medtronic. Dr. Reimherr reports no financial relationships with commercial interests. Dr. Schwartz has received research funding from Cyberonics. Dr. Zajecka has received research support from Actavis, Alkermes, AstraZeneca, Cyberonics, Inc., EIMindA, Forest Laboratories, the Cheryl T. Herman Foundation, Hoffman-La Roche, Janssen, Naurex, Otsuka, NIH, Shire, and Takeda and has served as a consultant or advisory board member for AbbVie, Avanir, Eli Lilly, Forest Laboratories, Naurex, Lundbeck, Nestle Health Science-Pamlab, Shire, and Takeda.
PY - 2017/7/1
Y1 - 2017/7/1
N2 - Objective: 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. Method: 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. Results: 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%). Conclusions: 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.
AB - Objective: 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. Method: 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. Results: 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%). Conclusions: 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.
UR - http://www.scopus.com/inward/record.url?scp=85021708725&partnerID=8YFLogxK
U2 - 10.1176/appi.ajp.2017.16010034
DO - 10.1176/appi.ajp.2017.16010034
M3 - Article
C2 - 28359201
AN - SCOPUS:85021708725
VL - 174
SP - 640
EP - 648
JO - American Journal of Psychiatry
JF - American Journal of Psychiatry
SN - 0002-953X
IS - 7
ER -