Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised, sham-controlled trial

被引：389

作者：

Holtzheimer, Paul E. ^{[1
,2
]}

Husain, Mustafa M. ^{[3
,6
]}

Lisanby, Sarah H. ^{[7
]}

Taylor, Stephan F. ^{[8
]}

Whitworth, Louis A. ^{[4
]}

McClintock, Shawn ^{[5
,6
]}

Slavin, Konstantin V. ^{[10
]}

Berman, Joshua ^{[11
]}

McKhann, Guy M. ^{[12
]}

Patil, Parag G. ^{[9
]}

Rittberg, Barry R. ^{[13
]}

Abosch, Aviva ^{[14
,15
]}

Pandurangi, Ananda K. ^{[16
]}

Holloway, Kathryn L. ^{[17
]}

Lam, Raymond W. ^{[18
]}

Honey, Christopher R. ^{[19
]}

Neimat, Joseph S. ^{[20
]}

Henderson, Jaimie M. ^{[21
]}

DeBattista, Charles ^{[22
]}

Rothschild, Anthony J. ^{[23
,24
]}

Pilitsis, Julie G. ^{[25
,26
]}

Espinoza, Randall T. ^{[27
]}

Petrides, Georgios ^{[28
,29
]}

Mogilner, Alon Y. ^{[30
]}

Matthews, Keith ^{[31
,32
]}

Peichel, DeLea ^{[33
]}

Gross, Robert E. ^{[34
]}

Hamani, Clement ^{[37
]}

Lozano, Andres M. ^{[38
]}

Mayberg, Helen S. ^{[35
,36
]}

机构：

[1] Dartmouth Hitchcock Med Ctr, Dept Psychiat, Lebanon, NH 03756 USA

[2] Dartmouth Hitchcock Med Ctr, Dept Surg, Lebanon, NH 03766 USA

[3] Univ Texas Southwestern Med Ctr Dallas, Dept Psychiat Neurol & Med, Dallas, TX 75390 USA

[4] Univ Texas Southwestern Med Ctr Dallas, Dept Neurol Surg, Neurol Surg, Radiat Oncol, Dallas, TX 75390 USA

[5] Univ Texas Southwestern Med Ctr Dallas, Dept Psychiat, Dallas, TX USA

[6] Duke Univ, Sch Med, Dept Psychiat & Behav Sci, Durham, NC USA

[7] NIMH, Rockville, MD 20857 USA

[8] Univ Michigan, Dept Psychiat, Ann Arbor, MI 48109 USA

[9] Univ Michigan, Dept Neurosurg Neurol Anesthesiol & Biomed Engn, Ann Arbor, MI 48109 USA

[10] Univ Illinois, Dept Neurosurg, Chicago, IL USA

[11] Columbia Univ Coll Phys & Surg, Dept Psychiat, Div Expt Therapeut, 722 W 168th St, New York, NY 10032 USA

[12] Columbia Univ, Med Ctr, New York Presbyterian Hosp, Dept Neurosurg, New York, NY USA

[13] Univ Minnesota, Dept Psychiat, Minneapolis, MN 55455 USA

[14] Univ Colorado, Dept Neurosurg, Anschutz Med Campus, Aurora, CO USA

[15] Univ Colorado, Dept Neurol, Anschutz Med Campus, Aurora, CO USA

[16] Commonwealth Univ, Dept Psychiat, Richmond, VA USA

[17] Commonwealth Univ, Dept Neurosurg, Richmond, VA USA

[18] Univ British Columbia, Dept Psychiat, Vancouver, BC, Canada

[19] Univ British Columbia, Dept Surg, Neurosurg, Vancouver, BC, Canada

[20] Univ Louisville, Dept Neurol Surg, Louisville, KY 40292 USA

[21] Stanford Univ, Sch Med, Stanford Dept Neurosurg, Stanford, CA USA

[22] Stanford Univ, Sch Med, Dept Psychiat, Stanford, CA USA

[23] Univ Massachusetts, Sch Med, Dept Psychiat, Worcester, MA 01655 USA

[24] UMass Mem HealthCare, Worcester, MA USA

[25] Albany Med Coll, Dept Neurosci & Expt Therapeut, Albany, NY 12208 USA

[26] Albany Med Coll, Dept Neurosurg, Albany, NY 12208 USA

[27] Univ Calif Los Angeles, Dept Psychiat & Behav Sci, Los Angeles, CA USA

[28] Northwell Hlth Syst, Zucker Hillside Hosp, Glen Oaks, NY USA

[29] Hofstra Northwell Sch Med, Glen Oaks, NY USA

[30] NYU, Dept Neurosurg, Langone Med Ctr, Ctr Neuromodulat, 550 1St Ave, New York, NY 10016 USA

[31] Univ Dundee, Sch Med, Div Neurosci, Dundee, Scotland

[32] Ninewells Hosp & Med Sch, Adv Intervent Serv, NHS Tayside, Dundee, Scotland

[33] Abbott, Clin Studies Dept, Plano, TX USA

[34] Emory Univ, Sch Med, Dept Neurosurg, Atlanta, GA USA

[35] Emory Univ, Sch Med, Dept Psychiat, Atlanta, GA 30322 USA

[36] Emory Univ, Sch Med, Dept Neurol, Atlanta, GA 30322 USA

[37] Toronto Western Hosp, Behav Neurobiol Lab, Campbell Family Mental Hlth Res Inst, Ctr Addict & Mental Hlth & Div Neurosurg, Toronto, ON, Canada

[38] Toronto Western Hosp, Dept Neurosurg & Neurosci, Toronto, ON, Canada

来源：

LANCET PSYCHIATRY | 2017年 / 4卷 / 11期

关键词：

VAGUS NERVE-STIMULATION; DOUBLE-BLIND; PARKINSONS-DISEASE; GYRUS; MULTICENTER; SURGERY; CORTEX; TERM;

D O I：

10.1016/S2215-0366(17)30371-1

中图分类号：

R749 [精神病学];

学科分类号：

100204 [神经病学];

摘要：

Background Deep brain stimulation (DBS) of the subcallosal cingulate white matter has shown promise as an intervention for patients with chronic, unremitting depression. To test the safety and efficacy of DBS for treatment resistant depression, a prospective, randomised, sham-controlled trial was conducted. Methods Participants with treatment-resistant depression were implanted with a DBS system targeting bilateral subcallosal cingulate white matter and randomised to 6 months of active or sham DBS, followed by 6 months of open label subcallosal cingulate DBS. Randomisation was computer generated with a block size of three at each site before the site started the study. The primary outcome was frequency of response (defined as a 40% or greater reduction in depression severity from baseline) averaged over months 4-6 of the double-blind phase. A futility analysis was performed when approximately half of the proposed sample received DBS implantation and completed the double-blind phase. At the conclusion of the 12-month study, a subset of patients were followed up for up to 24 months. The study is registered at ClinicalTrials. gov, number NCT00617162. Findings Before the futility analysis, 90 participants were randomly assigned to active (n=60) or sham (n=30) stimulation between April 10, 2008, and Nov 21, 2012. Both groups showed improvement, but there was no statistically significant difference in response during the double-blind, sham-controlled phase (12 [20%] patients in the stimulation group vs five [17%] patients in the control group). 28 patients experienced 40 serious adverse events; eight of these (in seven patients) were deemed to be related to the study device or surgery. Interpretation This study confirmed the safety and feasibility of subcallosal cingulate DBS as a treatment for treatment-resistant depression but did not show statistically significant antidepressant efficacy in a 6-month double-blind, sham-controlled trial. Future studies are needed to investigate factors such as clinical features or electrode placement that might improve efficacy.

引用

页码：839 / 849

页数：11

共 24 条

[1]

Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression A Randomized Clinical Trial [J].

Bergfeld, Isidoor O. ;

Mantione, Mariska ;

Hoogendoorn, Mechteld L. C. ;

Ruhe, Henricus G. ;

Notten, Peter ;

van Laarhoven, Jan ;

Visser, Ieke ;

Figee, Martijn ;

de Kwaasteniet, Bart P. ;

Horst, Ferdinand ;

Schene, Aart H. ;

van den Munckhof, Pepijn ;

Beute, Guus ;

Schuurman, Rick ;

Denys, Damiaan .

JAMA PSYCHIATRY, 2016, 73 (05) :456-464

[2]

Neurosurgical Treatments for Patients with Chronic, Treatment-Refractory Depression: A Retrospective, Consecutive, Case Series Comparison of Anterior Capsulotomy, Anterior Cingulotomy and Vagus Nerve Stimulation [J].

Christmas, David ;

Matthews, Keith .

STEREOTACTIC AND FUNCTIONAL NEUROSURGERY, 2015, 93 (06) :387-392

[3]

Prospective, long-term, multicenter study of the naturalistic outcomes of patients with treatment-resistant depression [J].

Dunner, David L. ;

Rush, A. John ;

Russell, James M. ;

Burke, Michael ;

Woodard, Stacy ;

Wingard, Peggy ;

Allen, John .

JOURNAL OF CLINICAL PSYCHIATRY, 2006, 67 (05) :688-695

[4]

A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression [J].

George, MS ;

Rush, AJ ;

Marangell, LB ;

Sackeim, HA ;

Brannan, SK ;

Davis, SM ;

Howland, R ;

Kling, MA ;

Moreno, F ;

Rittberg, B ;

Dunner, D ;

Schwartz, T ;

Carpenter, L ;

Burke, M ;

Ninan, P ;

Goodnick, P .

BIOLOGICAL PSYCHIATRY, 2005, 58 (05) :364-373

[5]

Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions [J].

Goetz, Christopher G. ;

Wuu, Joanne ;

McDermott, Michael P. ;

Adler, Charles H. ;

Fahn, Stanley ;

Freed, Curt R. ;

Hauser, Robert A. ;

Olanow, Warren C. ;

Shoulson, Ira ;

Tandon, P. K. ;

Leurgans, Sue .

MOVEMENT DISORDERS, 2008, 23 (05) :690-699

[6]

Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson's disease: a double-blind, randomised, controlled trial [J].

Gross, Robert E. ;

Watts, Raymond L. ;

Hauser, Robert A. ;

Bakay, Roy A. E. ;

Reichmann, Heinz ;

von Kummer, Ruediger ;

Ondo, William G. ;

Reissig, Elke ;

Eisner, Wilhelm ;

Steiner-Schulze, Heike ;

Siedentop, Harald ;

Fichte, Klaus ;

Hong, Walter ;

Cornfeldt, Michael ;

Beebe, Katherine ;

Sandbrink, Rupert .

LANCET NEUROLOGY, 2011, 10 (06) :509-519

[7]

Deep brain stimulation of the subcallosal cingulate gyrus for depression: anatomical location of active contacts in clinical responders and a suggested guideline for targeting Clinical article [J].

Hamani, Clement ;

Mayberg, Helen ;

Snyder, Brian ;

Giacobbe, Peter ;

Kennedy, Sidney ;

Lozano, Andres M. .

JOURNAL OF NEUROSURGERY, 2009, 111 (06) :1209-1215

[8]

Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Unipolar and Bipolar Depression [J].

Holtzheimer, Paul E. ;

Kelley, Mary E. ;

Gross, Robert E. ;

Filkowski, Megan M. ;

Garlow, Steven J. ;

Barrocas, Andrea ;

Wint, Dylan ;

Craighead, Margaret C. ;

Kozarsky, Julie ;

Chismar, Ronald ;

Moreines, Jared L. ;

Mewes, Klaus ;

Posse, Patricio Riva ;

Gutman, David A. ;

Mayberg, Helen S. .

ARCHIVES OF GENERAL PSYCHIATRY, 2012, 69 (02) :150-158

[9]

Deep Brain Stimulation for Treatment-Resistant Depression: Follow-Up After 3 to 6 Years [J].

Kennedy, Sidney H. ;

Giacobbe, Peter ;

Rizvi, Sakina J. ;

Placenza, Franca M. ;

Nishikawa, Yasunori ;

Mayberg, Helen S. ;

Lozano, Andres M. .

AMERICAN JOURNAL OF PSYCHIATRY, 2011, 168 (05) :502-510

[10]

Epidural Cortical Stimulation of the Left Dorsolateral Prefrontal Cortex for Refractory Major Depressive Disorder [J].

Kopell, Brian Harris ;

Halverson, Jerry ;

Butson, Christopher R. ;

Dickinson, Mercedes ;

Bobholz, Julie ;

Harsch, Harold ;

Rainey, Charles ;

Kondziolka, Douglas ;

Howland, Robert ;

Eskandar, Emad ;

Evans, Karleyton C. ;

Dougherty, Darin D. .

NEUROSURGERY, 2011, 69 (05) :1015-1029

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