TY - JOUR
T1 - Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression
T2 - Clinical predictors of outcome in a multisite, randomized controlled clinical trial
AU - Lisanby, Sarah H.
AU - Husain, Mustafa M.
AU - Rosenquist, Peter B.
AU - Maixner, Daniel
AU - Gutierrez, Rosben
AU - Krystal, Andrew
AU - Gilmer, William
AU - Marangell, Lauren B.
AU - Aaronson, Scott
AU - Daskalakis, Zafiris J.
AU - Canterbury, Randolph
AU - Richelson, Elliott
AU - Sackeim, Harold A.
AU - George, Mark S.
N1 - Funding Information:
Dr George reports the following relationships with pharmaceutical companies: Argolyn (consultantFpast), Aventis (consultantFpast), Bristol-Meyers Squibb (consultant), Cortex (Clinical Trial Research GrantFpast), DarPharma (Imaging Research Grant), GlaxoSmithKline (Imaging Research Grant and Speakers Bureau), Janssen Pharmaceuticals (Imaging Research Grant and Speakers BureauFpast), Jazz Pharmaceuticals (research grant/consultant), Lilly Pharmaceuticals (Imaging Research Grant and Speakers BureauFpast), Parke-Davis (Imaging Research GrantFpast, Speakers Bureau, consultant), Solvay/ Duphar (Imaging Research GrantFpast). Dr George also reports the following relationships with imaging and stimulation device companies: Aspect Medical (DSMB member, consultant), Brainsway (consultant, research grant), Brainsonix (advisory boardFunpaid), Cephos (advisory boardFunpaid and research grant), Cyberonics Inc. (Clinical Research Grants, Imaging Grant, Speakers Bureau, Depression Advisory Board, Mechanisms of Action Advisory Board), Dantec (Medtronic) (Formal Research Collaborations on TMS and DBS), Dupont Pharma (Imaging Research GrantFpast), Mediphysics/Amersham (Imaging Research Grant, Speakers BureauFpast), Neotonus (now Neuronetics) (Clinical Research Grant, consultantFpast, advisory boardFunpaid), NeuroPace (advisory board), Picker International (now Phillips) (Formal Research Collaboration on MRIFpast). Dr George reports no equity ownership in any device or pharmaceutical company. His total industry-related compensation is <10% of his university salary. MUSC has filed eight patents or invention disclosures in his name regarding brain imaging and stimulation devices.
Funding Information:
We thank the patients who participated in this clinical trial. In addition, we acknowledge the members of the Neuro-netics TMS Steering Committee (Alan F Schatzberg, Stanford University; Mark S George, Medical University of South Carolina; Harold A Sackeim, Columbia University; Mark A Demitrack, Neuronetics Inc.) and the principal investigators who were members of the Neuronetics TMS Study Group and their staff; Scott Aaronson, Sheppard Pratt Health System; David Avery, University of Washington Medical Center; Randolph Canterbury, University of Virginia; Zafiris J Daskalakis, Centre for Addiction and Mental Health; James Ferguson, Radiant Research; Paul Fitzgerald, The Alfred Psychiatry Research Centre; William Gilmer, Northwestern University; Rosben Guiterrez, Psy-Care Inc.; Mustafa Husain, University of Texas-South-western Medical Center; Keith Isenberg, Washington University School of Medicine; Philip G Janicak, Rush University Medical Center; Andrew Krystal, Duke University Medical Center; Sarah H Lisanby, New York State Psychiatric Institute/Columbia University; Colleen Loo, University of New South Wales; Daniel Maixner, University of Michigan Medical Center; Lauren Marangell, Baylor College of Medicine; William McDonald, Emory University; Ziad Nahas, Medical University of South Carolina; John P O’Reardon, University of Pennsylvania; Elliot Richelson, Shirlene Sampson, Mayo Clinic; Peter Rosenquist, Wake Forest University Health Sciences; Brent Solvason, Stanford University. This study was supported by a grant from Neuronetics Inc.
Funding Information:
Dr Gilmer has received research support from, served in advisory capacity to, or received speakers honoraria from Abbott Laboratories; Aspect Medical Systems; AstraZeneca; Bristol-Myers Squibb; Forest Pharmaceuticals; GlaxoS-mithKline; Janssen Pharmaceutica; National Institute of Mental Health, Neuronetics; Northwestern University; Novartis; and Pfizer.
Funding Information:
Dr Krystal has received patent royalties to Duke University from the MECTA Corp; research support from NIH, Sanofi-Aventis, Cephalon, GlaxoSmithKline, Merck, Neurocrine, Pfizer, Sepracor, Somaxon, Takeda, Transcept, Respironics, Evotec, Astellas; consulting fees from Actelion, Arena, Astellas, Axiom, AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, GlaxoSmithKline, Jazz, Johnson and Johnson, King, Merck, Neurocrine, Neurogen, Novartis, Organon, Pfizer, Respironics, Sanofi-Aventis, Sepracor, Somaxon, Takeda, Transcept, Astellas, Research Triangle Institute; and Speakers Bureau fees from Sleep Medicine Education Institute, Sepracor, and Sanofi-Aventis.
Funding Information:
The authors declare that this work was funded by a research grant from Neuronetics (the manufacturer of the device used in this trial). Each author received a research grant from Neuronetics to conduct this trial.
PY - 2009/1
Y1 - 2009/1
N2 - Randomized controlled trials support the antidepressant efficacy of transcranial magnetic stimulation (TMS); however, there is individual variability in the magnitude of response. Examination of response predictors has been hampered by methodological limitations such as small sample sizes and single-site study designs. Data from a multisite sham-controlled trial of the antidepressant efficacy of TMS provided an opportunity to examine predictors of acute outcome. An open-label extension for patients who failed to improve provided the opportunity for confirmatory analysis. Treatment was administered to the left dorsolateral prefrontal cortex at 10 pulses per second, 120% of motor threshold, for a total of 3000 pulses per day. Change on the Montgomery-Asberg Depression Rating Scale after 4 weeks was the primary efficacy outcome. A total of 301 patients with nonpsychotic unipolar major depression at 23 centers were randomized to active or sham TMS. Univariate predictor analyses showed that the degree of prior treatment resistance in the current episode was a predictor of positive treatment outcome in both the controlled study and the open-label extension trial. In the randomized trial, shorter duration of current episode was also associated with a better outcome. In the open-label extension study, absence of anxiety disorder comorbidity was associated with an improved outcome, but duration of current episode was not. The number of prior treatment failures was the strongest predictor for positive response to acute treatment with TMS. Shorter duration of current illness and lack of anxiety comorbidity may also confer an increased likelihood of good antidepressant response to TMS.
AB - Randomized controlled trials support the antidepressant efficacy of transcranial magnetic stimulation (TMS); however, there is individual variability in the magnitude of response. Examination of response predictors has been hampered by methodological limitations such as small sample sizes and single-site study designs. Data from a multisite sham-controlled trial of the antidepressant efficacy of TMS provided an opportunity to examine predictors of acute outcome. An open-label extension for patients who failed to improve provided the opportunity for confirmatory analysis. Treatment was administered to the left dorsolateral prefrontal cortex at 10 pulses per second, 120% of motor threshold, for a total of 3000 pulses per day. Change on the Montgomery-Asberg Depression Rating Scale after 4 weeks was the primary efficacy outcome. A total of 301 patients with nonpsychotic unipolar major depression at 23 centers were randomized to active or sham TMS. Univariate predictor analyses showed that the degree of prior treatment resistance in the current episode was a predictor of positive treatment outcome in both the controlled study and the open-label extension trial. In the randomized trial, shorter duration of current episode was also associated with a better outcome. In the open-label extension study, absence of anxiety disorder comorbidity was associated with an improved outcome, but duration of current episode was not. The number of prior treatment failures was the strongest predictor for positive response to acute treatment with TMS. Shorter duration of current illness and lack of anxiety comorbidity may also confer an increased likelihood of good antidepressant response to TMS.
KW - Clinical trial
KW - Major depression
KW - Predictors
KW - TMS study group
KW - Transcranial magnetic stimulation
KW - Treatment resistance
UR - http://www.scopus.com/inward/record.url?scp=57849166192&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=57849166192&partnerID=8YFLogxK
U2 - 10.1038/npp.2008.118
DO - 10.1038/npp.2008.118
M3 - Article
C2 - 18704101
AN - SCOPUS:57849166192
SN - 0893-133X
VL - 34
SP - 522
EP - 534
JO - Neuropsychopharmacology
JF - Neuropsychopharmacology
IS - 2
ER -