A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression - PubMed (original) (raw)
Randomized Controlled Trial
. 2015 Aug 15;78(4):240-8.
doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13.
Ali R Rezai 2, Linda L Carpenter 3, Robert H Howland 4, Mahendra T Bhati 5, John P O'Reardon 6, Emad N Eskandar 7, Gordon H Baltuch 8, Andre D Machado 9, Douglas Kondziolka 10, Cristina Cusin 11, Karleyton C Evans 11, Lawrence H Price 3, Karen Jacobs 2, Mayur Pandya 2, Timothey Denko 4, Audrey R Tyrka 3, Tim Brelje 12, Thilo Deckersbach 11, Cynthia Kubu 2, Donald A Malone Jr 2
Affiliations
- PMID: 25726497
- DOI: 10.1016/j.biopsych.2014.11.023
Randomized Controlled Trial
A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression
Darin D Dougherty et al. Biol Psychiatry. 2015.
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.
Keywords: DBS; Deep brain stimulation; Major depression; TRD; Treatment resistant depression; Ventral capsule/ventral striatum.
Copyright © 2015 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
Comment in
- Deep Brain Stimulation for Major Depression-Steps on a Long and Winding Road.
Schlaepfer TE. Schlaepfer TE. Biol Psychiatry. 2015 Aug 15;78(4):218-9. doi: 10.1016/j.biopsych.2015.06.020. Biol Psychiatry. 2015. PMID: 26195174 No abstract available. - The Enduring Vitality of Implausible Claims for Neurostimulation and Psychosurgical Therapies.
Coffey RJ. Coffey RJ. Stereotact Funct Neurosurg. 2015;93(5):366-9. doi: 10.1159/000437390. Epub 2015 Oct 8. Stereotact Funct Neurosurg. 2015. PMID: 26444852 No abstract available. - A negative randomised sham-controlled trial of ventral capsule/ventral striatum stimulation in treatment-resistant depression: an unsuccessful trial or treatment?
Ramasubbu R. Ramasubbu R. Evid Based Ment Health. 2016 May;19(2):59. doi: 10.1136/eb-2015-102110. Epub 2016 Jan 14. Evid Based Ment Health. 2016. PMID: 26767391 Free PMC article. No abstract available.
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