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Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Major Depression

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Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Major Depression RESEARCH REPORT Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial 1 2 3 4 5 YECHIEL LEVKOVITZ ,MOSHE ISSERLES ,FRANK PADBERG ,SARAH H. LISANBY ,ALEXANDER BYSTRITSKY , 6 7 8 9 10 GUOHUA XIA ,ARON TENDLER ,ZAFIRIS J. DASKALAKIS ,JARON L. WINSTON ,PINHAS DANNON , 11 12 13 14 15 HISHAM M. HAFEZ ,IRVING M. RETI ,OSCAR G. MORALES ,THOMAS E. SCHLAEPFER ,ERIC HOLLANDER , 16 17 18 19 19 JOSHUA A. BERMAN ,MUSTAFA M. HUSAIN ,UZI SOFER ,AHAVA STEIN ,SHMULIK ADLER , 20 20 21 22 21 LISA DEUTSCH ,FREDERIC DEUTSCH ,YIFTACH ROTH ,MARK S. GEORGE ,ABRAHAM ZANGEN 1Shalvata Mental Health Center, Tel Aviv University, Hod Hasharon, Israel; 2Department of Psychiatry, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 3Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany; 4Department of Psychiatry and Behavioral Sciences and Department of Psychology and Neuroscience, Duke University, Durham, NC, USA; 5Department of Psychiatry and Biobehavioral Sciences, University of Cal- ifornia, Los Angeles, CA, USA; 6UC Davis Center for Mind and Brain and Department of Psychiatry and Behavioral Science, University of California, Davis, CA, USA; 7Advanced Mental Health Care Inc., Royal Palm Beach, FL, USA; 8Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada; 9Senior Adult Specialty Healthcare, Austin, TX, USA; 10Beer Yaakov Mental Health Center, Tel Aviv University, Beer Yaakov, Israel; 11Greater Nashua Mental Health Center, Nashua, NH, USA; 12Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 13McLean Hospital and Harvard Medical School, Belmont, MA, USA; 14Department of Psychiatry and Psychotherapy, University Hospital, Bonn, Germany; 15Spectrum Neuroscience and Treatment Center, New York, NY, USA; 16Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, NY, USA; 17Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA; 18Brainsway Ltd., Jerusalem, Israel; 19A. Stein - Regulatory Affairs Consulting Ltd., Kfar Saba, Israel; 20Biostatistical Consulting, BioStats, Israel; 21Department of Life Sciences, Ben-Gurion University of the Negev, Be’er Sheva, Israel; 22Psychiatry Department, Brain Stimulation Laboratory, Medical University of South Carolina and Ralph H. Johnson VA Medical Center, Charleston, SC, USA Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD out- patients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments dur- ing the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p50.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p50.013; remission: 32.6 vs. 14.6%, p50.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. Key words: Deep transcranial magnetic stimulation, major depressive disorder, treatment resistance, response, remission, maintenance treatment (World Psychiatry 2015;14:64–73) Major depressive disorder (MDD) is a highly prevalent The H-coil is a novel rTMS tool, which enables direct and disabling condition associated with significant morbidi- stimulation of deeper and larger brain volumes (7-10). This ty and mortality (1,2). It has been estimated that 20-40% of coil is designed to affect extensive neuronal pathways, patients do not benefit adequately from available interven- including deeper cortical regions and fibers targeting sub- tions, including pharmacotherapy and psychotherapy (3). cortical regions, without a significant increase of the electric The lack of sufficient treatment response and the enormous field induced in superficial cortical layers (7-10). Several impact of the disorder make the development of alternative open feasibility studies showed a clinically meaningful ther- treatment approaches a priority. apeutic action of H-coil deep TMS (dTMS), which was Repetitive transcranial magnetic stimulation (rTMS) has maintained by continuation of treatment for up to 18 weeks been proposed as one such novel treatment (4-6). TMS (11-15). These initial studies suggested that a stimulation involves passing an electrical current through a coil placed intensity of 120% of the individual resting motor threshold against the scalp. The rapidly changing electrical current (but not a more shallow stimulation induced by lower inten- creates a time-varying magnetic field, which passes unim- sities) induces an antidepressant response. peded through the scalp and skull and induces an electrical Conventional rTMS procedures have been investigated field in the cortex. This electrical field changes neuronal in several psychiatric disorders, including unipolar depres- activity at the site of stimulation and within interconnected sion, schizophrenia and bipolar disorder (16-18). A small neuronal networks. TMS pulses applied in a repetitive train number of acute (3-6 week) large scale randomized con- is referred to as rTMS. trolled multicenter trials have examined the antidepressant 64 World Psychiatry 14:1 - February 2015 properties of conventional rTMS applied over the left dorso- Subjects lateral prefrontal cortex (DLPFC) (19-21). Two of these studies showed significant antidepressant effects of rTMS, Patients were recruited via public media advertisements compared to placebo, in medication-free patients who had and physician referrals. Site personnel phone-screened not responded to previous antidepressant treatment (19,21). potential participants, and those meeting inclusion and ex- Though antidepressant properties of prefrontal rTMS clusion criteria underwent additional on-site screening. have been clearly demonstrated in patients who did not All subjects signed an informed consent document before respond to one antidepressant medication in the current undergoing any study procedures. episode, response and remission rates in these large con- Eligible subjects were antidepressant medication-free trolled trials were small to moderate. Therefore, additional (following the wash-out period) outpatients, aged 22-68 multicenter sham-controlled studies are needed to establish years, with a DSM-IV diagnosis of MDD, single or recurrent the short- and long-term efficacy of rTMS in patients suffer- episode. The duration of current episode was at least one ing from therapy-resistant MDD (19,22). month but no more than 7 years. Subjects were required to In this study, we have addressed two key issues that may have a Clinical Global Impression Severity of Illness (CGI- be critical for the antidepressant effect of rTMS. First, most S) score of at least 4 and a total score of at least 20 on the clinical rTMS protocols have stimulated the left DLPFC. 21-item Hamilton Depression Rating Scale (HDRS-21) at Recent studies have shown that different DLPFC subregions screening visit. Symptom stability was required during the stimulated by standard protocols vary considerably in terms 2-week wash-out period. Instability was defined as a change of their connectivity with medial prefrontal structures such of 630% or more from the total HDRS-21 score that was as the subgenual cingulate gyrus (23,24), which appears to observed at the screening assessment. be an important region involved in the pathophysiology of Antidepressant treatment resistance during the current MDD (25). Thus, it may be advantageous to stimulate less episode was assessed using the Antidepressant Treatment focally and more deeply to reach connecting fiber tracts. History Form (ATHF, 26). Subjects were required to have Second, conventional rTMS has been investigated over failed at least one but no more than four adequate antide- short acute treatment periods ranging from 3 to 6 weeks. pressant treatments, or to have had intolerance to at least The clinical durability of antidepressant effects over longer two antidepressants in the current episode. periods has not been studied before in randomized con- Subjects were excluded if they had a lifetime history of trolled trials. psychosis, bipolar disorder, obsessive-compulsive disorder We conducted a double-blind randomized placebo-con- (current or within the past year),
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