@article{c510603b77264a8191aef347a16945cc,
title = "A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression",
abstract = "Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label continuation phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery-{\AA}sberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery-{\AA}sberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial. The response rates at 12, 18, and 24 months during the open-label continuation phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label continuation phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.",
keywords = "DBS, Deep brain stimulation, Major depression, TRD, Treatment resistant depression, Ventral capsule/ventral striatum",
author = "Dougherty, {Darin D.} and Rezai, {Ali R.} and Carpenter, {Linda L.} and Howland, {Robert H.} and Bhati, {Mahendra T.} and O'Reardon, {John P.} and Eskandar, {Emad N.} and Baltuch, {Gordon H.} and Machado, {Andre D.} and Douglas Kondziolka and Cristina Cusin and Evans, {Karleyton C.} and Price, {Lawrence H.} and Karen Jacobs and Mayur Pandya and Timothey Denko and Tyrka, {Audrey R.} and Tim Brelje and Thilo Deckersbach and Cynthia Kubu and Malone, {Donald A.}",
note = "Funding Information: All authors have received research support from Medtronic, Inc., the sponsor company of the clinical trial reported in this manuscript. In the last two years, Dr. Dougherty has received honoraria from Reed Elsevier and Medtronic. He has also served as a consultant to Medtronic and received grant/research support from Eli Lilly, Cyberonics, and Roche. Dr. Rezai is on the Board of Directors for Autonomic Technologies and is also an Equity holder. Dr. Carpenter has received research support from Neuronetics Inc., NeoSync Inc., and Cervel Neurotech Inc. through clinical trials with Butler Hospital. Dr. Carpenter also reports a consulting relationship with Magstim. Dr. Howland has received grant/research support from National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression, Cyberonics, NeoSync, Corcept, Takeda, Otsuka, and Shire. Dr. Bhati has received research funding from the American Psychiatric Association, NeoSync, and Cyberonics. Dr. Baltuch has received support from Defense Advanced Research Projects Agency. Dr. Machado is a consultant to Functional Neuromodulation and Spinal Modulation. He has distribution rights related to Intellectual Property from Enspire, Autonomic Technologies, Inc. and Cardionomics. He also has fellowship support from Medtronic. Dr. Evans has received grant support from Cyberonics and Pfizer. He is currently an employee and shareholder of Biogen Idec. Dr. Price has served on an advisory panel for Abbott. Additionally, he has served as a consultant to Wiley, Springer, Qatar National Research Fund, and Abbott and has received grant/research support from Neuronetics, National Institutes of Health (NIH) NeoSync, and Cervel Neurotech. Dr. Jacobs has received honoraria from Takeda and the Lundbeck Speaker Bureau. Dr. Pandya has received honoraria from the Lundbeck Speaker Bureau. Dr. Tyrka has received grant/research support from Neuronetics, NIH, NeoSync, and Cervel Neurotech. Dr O׳Reardon has served as a consultant to IC Axon, Lilly, and Neuronetics. He has also received grant/research support from NeoSync, Stanley Medical Research Institute, AstraZeneca, BMS, CeNeRX Biopharma, Cyberonics, Neuronetics, Pfizer, Sanofi, and Magstim. Mr. Brelje is an employee and shareholder of Medtronic. Dr. Deckersbach׳s research has been funded by NIMH, National Alliance for Research on Schizophrenia and Depression, Tourette Syndrome Association, International OCD Foundation, Tufts University and Depressive and Bipolar Disorder Alternative Treatment Foundation. He has received honoraria, consultation fees and/or royalties from the Massachusetts General Hospital Psychiatry Academy, BrainCells Inc., Clintara, LLC, Systems Research and Applications Corporation, Boston University, the Catalan Agency for Health Technology Assessment and Research, the National Association of Social Workers Massachusetts, the Massachusetts Medical Society, Tufts University, National Institute on Drug Abuse, and Oxford University Press. He has also participated in research funded by DARPA, NIH, NIMH, National Institute on Aging, Agency for Healthcare Research and Quality, Patient-Centered Outcomes Research Institute, Janssen Pharmaceuticals, The Forest Research Institute, Shire Development Inc., Cyberonics, Northstar, and Takeda. Dr. Kubu has received research support from the NIH. Dr. Malone has served on an advisory board for Astra Zeneca. He has also received grant/research support from the NIH. All other authors report no additional financial interests or potential conflicts of interests. Publisher Copyright: {\textcopyright} 2015 Society of Biological Psychiatry. Copyright: Copyright 2016 Elsevier B.V., All rights reserved.",
year = "2015",
month = aug,
day = "15",
doi = "10.1016/j.biopsych.2014.11.023",
language = "English (US)",
volume = "78",
pages = "240--248",
journal = "Biological Psychiatry",
issn = "0006-3223",
publisher = "Elsevier USA",
number = "4",
}