TY - JOUR
T1 - International randomized-controlled trial of transcranial Direct Current Stimulation in depression
AU - Loo, Colleen K.
AU - Husain, Mustafa M.
AU - McDonald, William M.
AU - Aaronson, Scott
AU - O'Reardon, John P.
AU - Alonzo, Angelo
AU - Weickert, Cynthia Shannon
AU - Martin, Donel M.
AU - McClintock, Shawn M.
AU - Mohan, Adith
AU - Lisanby, Sarah H.
N1 - Funding Information:
This trial was supported by a Stanley Medical Research Foundation Research grant for investigator initiated research, awarded to Dr Loo and colleagues. Equipment for the study was provided by the Soterix Medical company. Soterix Medical had no role in study design, data collection, analysis, interpretation or reporting of results. Likewise, the study sponsor, the University of New South Wales (Australia) had no role in study design, data collection, analysis, interpretation or reporting of results. Cynthia Shannon Weickert is funded by the NSW Ministry of Health, Office of Health and Medical Research , and is a recipient of a National Health and Medical Research Council (Australia) Principal Research Fellowship (PRF) (# 1117079 ). Duke University: Richard Weiner, Steven Szabo, Michael Koval, Gabriela Asturias, Jonathan Young, Annie Jayanth, Chris Sikes-Keilp, Michael Olson, Susan Hilbig, Lis Bernhardt, Rosa Jou-Zhang; Emory University: Gail Galendez Snead, Gregory Job, Michele Miles; Neuroscience Research Australia: Roxanne Cadiz. Rowan University: Amanda Helmer, Michelle Nagurney; Sheppard Pratt Health System: Kathleen Conway; University of New South Wales: Stevan Nikolin, Kerrie-Anne Ho, Taariq Chew, Shani Lauf, Lucy McGuirk, Eileen Stech, Bronwyn Hegarty, Joyce Teng, Kevin Yeung, Jessica Sloey, Rosalyn Lai, Laura Cotiga, Duncan George, James Goldstein, Cristal Oxley; University of Texas Southwestern: Paige Baker, Najeeb Ranginwalla, Aatika Parwaiz. Appendix A
Funding Information:
This trial was supported by the Stanley Medical Research Foundation Research [grant number 11T-005 ].
Funding Information:
Scott Aaronson, Angelo Alonzo, Whitney Davis, Veronica Galvez, Mustafa M. Husain, Sarah H. Lisanby, Colleen K. Loo, Adith Mohan, O'Reardon and Jennifer Sklar report no biomedical financial interests or potential conflicts of interest. Ben Colagiuri holds research grants from the Australian Research Council . Andrew Krystal has received grant funding from the National Institutes of Health , Janssen and Jazz. He is also a consultant for Merck, Pfizer, Janssen, Atentiv, Flamel and Neurocentria. Donel Martin is a recipient of a NARSAD Young Investigator Award. Shawn McClintock reports research funding from the National Institutes of Health . He receives teaching honoraria from TMS Health Solutions. William McDonald has received funding or support from the Patient-Centered Outcomes Research Institute ( PCORI ), Stanley Foundation , Soterix, Neuronetics and Cervel Neurotherapeutics. He also receives reimbursement for travel and an honorarium of less than , Soterix, Neuronetics and Cervel Neurotherapeutics. He also receives reimbursement for travel and an honorarium of less than $1000 per year as a consultant on the Neurological Devices Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health, Food and Drug Administration and as an ad hoc member of several NIMH and NINDS study sections. He has a contract with Oxford University Press to co-edit a book on the Clinical Guide to Transcranial Magnetic Stimulation in the Treatment of Depression and is a section editor for Current Psychiatry Reports and is on the editorial boards for American Journal of Geriatric Psychiatry and Journal for ECT. He is a member of the American Psychiatric Association (APA) Council on Research representing ECT and Neuromodulation Therapies. Angel Peterchev is inventor on patents and patent applications and has received research and travel support as well as patent royalties from Rogue Research; research and travel support, consulting fees, as well as equipment loan from Tal Medical; patent application support from Magstim; and equipment loans from MagVenture, all related to technology for transcranial magnetic stimulation. He also receives research funding from the 000 per year as a consultant on the Neurological Devices Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health, Food and Drug Administration and as an ad hoc member of several NIMH and NINDS study sections. He has a contract with Oxford University Press to co-edit a book on the Clinical Guide to Transcranial Magnetic Stimulation in the Treatment of Depression and is a section editor for Current Psychiatry Reports and is on the editorial boards for American Journal of Geriatric Psychiatry and Journal for ECT. He is a member of the American Psychiatric Association (APA) Council on Research representing ECT and Neuromodulation Therapies. Angel Peterchev is inventor on patents and patent applications and has received research and travel support as well as patent royalties from Rogue Research; research and travel support, consulting fees, as well as equipment loan from Tal Medical; patent application support from Magstim; and equipment loans from MagVenture, all related to technology for transcranial magnetic stimulation. He also receives research funding from the National Institutes of Health , the National Science Foundation , North Carolina Biotechnology Center , and Duke University . Cynthia Shannon Weickert is on an advisory board for Lundbeck, Australia Pty Ltd and in collaboration with Astellas Pharma Inc., Japan.
Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/1
Y1 - 2018/1
N2 - Background Evidence suggests that transcranial Direct Current Stimulation (tDCS) has antidepressant effects in unipolar depression, but there is limited information for patients with bipolar depression. Additionally, prior research suggests that brain derived neurotrophic factor (BDNF) Val66Met genotype may moderate response to tDCS. Objective To examine tDCS efficacy in unipolar and bipolar depression and assess if BDNF genotype is associated with antidepressant response to tDCS. Methods 130 participants diagnosed with a major depressive episode were randomized to receive active (2.5 milliamps (mA), 30 min) or sham (0.034 mA and two 60-second current ramps up to 1 and 0.5 mA) tDCS to the left prefrontal cortex, administered in 20 sessions over 4 weeks, in a double-blinded, international multisite study. Mixed effects repeated measures analyses assessed change in mood and neuropsychological scores in participants with at least one post-baseline rating in the unipolar (N = 84) and bipolar (N = 36) samples. Results Mood improved significantly over the 4-week treatment period in both unipolar (p = 0.001) and bipolar groups (p < 0.001). Among participants with unipolar depression, there were more remitters in the sham treatment group (p = 0.03). There was no difference between active and sham stimulation in the bipolar sample. BDNF genotype was unrelated to antidepressant outcome. Conclusions Overall, this study found no antidepressant difference between active and sham stimulation for unipolar or bipolar depression. However, the possibility that the low current delivered in the sham tDCS condition was biologically active cannot be discounted. Moreover, BDNF genotype did not moderate antidepressant outcome. Clinical Trials Registration www.clinicaltrials.gov, NCT01562184.
AB - Background Evidence suggests that transcranial Direct Current Stimulation (tDCS) has antidepressant effects in unipolar depression, but there is limited information for patients with bipolar depression. Additionally, prior research suggests that brain derived neurotrophic factor (BDNF) Val66Met genotype may moderate response to tDCS. Objective To examine tDCS efficacy in unipolar and bipolar depression and assess if BDNF genotype is associated with antidepressant response to tDCS. Methods 130 participants diagnosed with a major depressive episode were randomized to receive active (2.5 milliamps (mA), 30 min) or sham (0.034 mA and two 60-second current ramps up to 1 and 0.5 mA) tDCS to the left prefrontal cortex, administered in 20 sessions over 4 weeks, in a double-blinded, international multisite study. Mixed effects repeated measures analyses assessed change in mood and neuropsychological scores in participants with at least one post-baseline rating in the unipolar (N = 84) and bipolar (N = 36) samples. Results Mood improved significantly over the 4-week treatment period in both unipolar (p = 0.001) and bipolar groups (p < 0.001). Among participants with unipolar depression, there were more remitters in the sham treatment group (p = 0.03). There was no difference between active and sham stimulation in the bipolar sample. BDNF genotype was unrelated to antidepressant outcome. Conclusions Overall, this study found no antidepressant difference between active and sham stimulation for unipolar or bipolar depression. However, the possibility that the low current delivered in the sham tDCS condition was biologically active cannot be discounted. Moreover, BDNF genotype did not moderate antidepressant outcome. Clinical Trials Registration www.clinicaltrials.gov, NCT01562184.
KW - Brain derived neurotrophic factor
KW - Depression
KW - Efficacy
KW - Randomized controlled trial
KW - Safety
KW - Transcranial direct current stimulation
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U2 - 10.1016/j.brs.2017.10.011
DO - 10.1016/j.brs.2017.10.011
M3 - Article
C2 - 29111077
AN - SCOPUS:85032182162
VL - 11
SP - 125
EP - 133
JO - Brain Stimulation
JF - Brain Stimulation
SN - 1935-861X
IS - 1
ER -