Darin D Dougherty1, Ali R Rezai2, Linda L Carpenter3, Robert H Howland4, Mahendra T Bhati5, John P O'Reardon6, Emad N Eskandar7, Gordon H Baltuch8, Andre D Machado9, Douglas Kondziolka10, Cristina Cusin11, Karleyton C Evans11, Lawrence H Price3, Karen Jacobs2, Mayur Pandya2, Timothey Denko4, Audrey R Tyrka3, Tim Brelje12, Thilo Deckersbach11, Cynthia Kubu2, Donald A Malone2. 1. Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: ddougherty@partners.org. 2. Department of Psychiatry and Psychology, Cleveland Clinic, Cleveland, Ohio. 3. Butler Hospital, Alpert Medical School of Brown University, Providence, Rhode Island. 4. Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh. 5. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 6. Department of Psychiatry, University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine, Stratford, New Jersey. 7. Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. 8. Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 9. Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio. 10. Department of Neurosurgery, New York University Langone Medical Center, New York University, New York, New York. 11. Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. 12. Medtronic, Inc, Minneapolis, Minnesota.
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-Åsberg 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-Åsberg 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.
RCT Entities:
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-Åsberg 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-Åsberg 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.
Authors: Lisanne M Jenkins; Kristy A Skerrett; Sophie R DelDonno; Víctor G Patrón; Kortni K Meyers; Scott Peltier; Jon-Kar Zubieta; Scott A Langenecker; Monica N Starkman Journal: Psychiatry Res Neuroimaging Date: 2018-03-05 Impact factor: 2.376
Authors: Morgan B Lee; Daniel R Kramer; Terrance Peng; Michael F Barbaro; Charles Y Liu; Spencer Kellis; Brian Lee Journal: J Clin Neurosci Date: 2019-07-30 Impact factor: 1.961