期刊
BIOLOGICAL PSYCHIATRY
卷 78, 期 4, 页码 240-248出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.biopsych.2014.11.023
关键词
Deep brain stimulation; DBS; Treatment resistant depression; TRD; Major depression; Ventral capsule/ventral striatum
资金
- Medtronic, Inc.
- Eli Lilly
- Cyberonics
- Roche
- Neuronetics Inc.
- NeoSync Inc.
- Cervel Neurotech Inc.
- National Institute of Mental Health (NIMH)
- National Alliance for Research on Schizophrenia and Depression
- NeoSync
- Corcept
- Takeda
- Otsuka
- Shire
- American Psychiatric Association
- Defense Advanced Research Projects Agency
- Medtronic
- Pfizer
- Neuronetics
- Cervel Neurotech
- NIH
- Stanley Medical Research Institute
- AstraZeneca
- BMS
- CeNeRX Biopharma
- Sanofi
- Magstim
- NIMH
- Tourette Syndrome Association
- International OCD Foundation
- Tufts University
- Depressive and Bipolar Disorder Alternative Treatment Foundation
- Massachusetts General Hospital Psychiatry Academy
- BrainCells Inc.
- Clintara, LLC
- Systems Research and Applications Corporation
- Boston University
- Catalan Agency for Health Technology Assessment and Research
- National Association of Social Workers Massachusetts
- Massachusetts Medical Society
- National Institute on Drug Abuse
- Oxford University Press
- DARPA
- National Institute on Aging
- Agency for Healthcare Research and Quality
- Patient-Centered Outcomes Research Institute
- Janssen Pharmaceuticals
- Forest Research Institute
- Shire Development Inc.
- Northstar
- National Institutes of Health (NIH) NeoSync
- Butler Hospital
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-Asberg 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-Asberg 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.
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