There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Comparisons at week 8 and regarding HAM-A were not statistically significant (Supplementary Table 1). The main eligibility criterion was the presence of a depressive episode of at least moderate intensity, corresponding to a Hamilton Depression Rating Scale (17-items; HDRS-17)>17 (Hamilton, 1960). 2016 Apr;75:107-15. doi: 10.1016/j.jpsychires.2015.12.019. J Psychiatr Res 74: 38–44. Brain Stimul 6: 1–13. Of ~280 volunteers, 268 were screened and 216 were excluded for several reasons (Figure 1). The Laboratory of Neuroscience receives financial support from the Beneficent Association Alzira Denise Hertzog da Silva. Recruitment strategies included referrals from physicians, patients from academic mood disorders clinics and advertisement through social media and local newspapers. The active stimulation consisted of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). depression in bipolar disorder but there are less data for mania. PubMed Psychol Med 44: 225–239. Deep TMS with the H1 coil is FDA approved for the treatment of depression in patients who have not improved by using any number of medications. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013. No TEMS episodes were observed. Bull World Health Organ 86: 650–652. Moreover, patients in the active group presented significantly greater improvement in the GAF and CGI scores. Bipol Disord 15: 61–69. Epub 2018 Apr 3. Therefore, our results should be interpreted as preliminary and hypothesis-driven for future, pivotal trials. All participants signed informed consent form. 2019;11(2):8-15. doi: 10.1108/MIJ-10-2019-0004. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. Kedzior KK, Gierke L, Gellersen HM, Berlim MT. Exclusion criteria included other neuropsychiatric conditions per DSM-IV criteria (such as unipolar depression, schizophrenia, substance dependence, dementias, traumatic brain injury, epilepsy, and others—although anxiety disorders as comorbidities were included, provided the primary diagnosis was bipolar disorder); severe personality disorders; presence of (hypo)manic symptoms at baseline and/or a Young Manic Rating Scale (YMRS)>12 points; rapid-cycling bipolar disorder; acute suicidal ideation; pregnancy; specific contraindications to rTMS and motor threshold (MT)>70% of maximum stimulator output assessed at the screening visit. Thank you for visiting nature.com. André R Brunoni. One novel approach includes the ‘deep’ (H1 coil) TMS (dTMS) (Levkovitz et al, 2015). The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Therefore, our findings point out that dTMS is a valid therapeutic option in such patients, whose treatment is particularly challenging, with only a few options currently available (Goodwin et al, 2016; Grunze et al, 2010; Malhi et al, 2015; Pacchiarotti et al, 2013; Yatham et al, 2013). Epub 2015 Dec 22. TMS is typically used when other depression treatments haven't been effective.This treatment for depression involves delivering repetitive magnetic pulses, so it's called repetitive TMS or rTMS. In fact, our dTMS response rate (48%) was similar than the rTMS response rate for BD (44.3%) according to a recent meta-analysis (McGirr et al, 2016)—possibly, the lack of a significant finding for response in our study occurred due to an underpowered analysis owing to a low sample size. Regarding predictors of response, we performed general linear models using the difference between baseline and week 4 or week 8 HDRS scores as the dependent variable. There were 2 and 5 dropouts in the sham and active groups, respectively. Logistic regressions were performed to assess response and remission rates between groups. CAS Austr N Z J Psychiatry 49: 1087–1206. We estimated that the effects of active vs sham dTMS would be similar than in findings from that preliminary study that compared the efficacy of the H1 vs H1L coil groups. Are there subtypes of bipolar depression? Parker GB, Graham RK (2017). Cognitive outcomes of the bipolar depression electrical treatment trial (BETTER): a randomized, double-blind, sham-controlled study. Clinical characteristics associated with treatment-resistant bipolar disorder. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibilitystudy. Scalp pain rates were higher in the active (20%) vs sham (0%) groups (p=0.05). Patients presenting psychotic depression at the time of assessment (but not those with a prior history of mood episodes with psychotic features) were also excluded, since ECT was consistently found to be better than rTMS in this subgroup of patients (Milev et al, 2016). We performed the first randomized, sham-controlled clinical assessing the efficacy, safety and tolerability of the H1-coil TMS for the treatment of resistant bipolar depression. In fact, large, pragmatic clinical trials in bipolar disorder showed that benzodiazepine use in patients with bipolar depression seems to be a marker for a more severe course of illness, presents a higher risk of recurrence and is associated with greater illness complexity and higher burden of disease (Bobo et al, 2015; Perlis et al, 2010). Can J Psychiatry 61: 561–575. Unlike ECT, TMS does not require the use of anesthesia and pers… Bipol Disord 15: 1–44. Improving the antidepressant efficacy of transcranial magnetic stimulation: maximizing the number of stimulations and treatment location in treatment-resistant depression. Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Moreover, the results of this meta-analysis were not available when our study was designed. Zimmerman M (2016). J Clin Psychiatry 59 (Suppl 20): 22–33. Li CT, Bai YM, Huang YL, Chen YS, Chen TJ, Cheng JY et al (2012). Comparisons regarding response and remission at week 8 were not statistically significant (Table 3). Two small randomized controlled … Analyses were performed in Stata 14 (Statacorp, College Station, TX, USA). In addition, our findings might not be generalizable to BD patients on concurrent AD therapy, as such patients were not included in the study. Bipol Disord 11: 453–473. In our study, we employed no maintenance schedule from weeks 4 to 8 devising that the mood stabilizers the patients were in use would sustain clinical improvement after the acute treatment phase. ISSN 1740-634X (online), Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial, Prevention of suicidal behavior in bipolar disorder, The efficacy of repetitive transcranial magnetic stimulation (rTMS) for bipolar depression: A systematic review and meta-analysis, Cognitive outcomes of the bipolar depression electrical treatment trial (BETTER): a randomized, double-blind, sham-controlled study, Treatment effect variability in brain stimulation across psychiatric disorders: A meta-analysis of variance, The Treatment of Bipolar Depression: Current Status and Future Perspectives. Allocation concealment consisted of sequentially numbered cards, which determined whether the TMS machine would produce real or sham stimulation. 2020;79(3):208-213. doi: 10.1159/000505405. No interactions between groups with any predictor variable, including type of bipolar disorder and number of failed effective treatments in the present episode, were found (Supplementary Table 3). Complexity of illness and adjunctive benzodiazepine use in outpatients with bipolar I or II disorder: results from the Bipolar CHOICE study. Pacchiarotti I, Bond DJ, Baldessarini RJ, Nolen WA, Grunze H, Licht RW et al (2013). Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy. Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. The OR for response and remission rates observed were lower than the ORs for rTMS in unipolar depression (Berlim et al, 2014), which can be explained given the lower response rates usually observed in BD (Tondo et al, 2014). Article Options for pharmacological treatment of refractory bipolar depression. Epub 2020 Jan 17. World J Biol Psychiatry 11: 81–109. BrainsWay’s* treatment offers an effective*, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation (TMS) for treating bipolar disorder. J Affect Disord 198: 158–162. Google Scholar. https://doi.org/10.1038/npp.2017.26, Journal of Affective Disorders Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Procedure: We report the case of a bipolar II patient, in which dTMS … Finally, dTMS was similarly effective for both bipolar I and bipolar II patients. Google Scholar. This clinical trial was designed to evaluate the efficacy of deep-TMS as an add-on therapy to resistant BD patients, due to the paucity of studies assessing the effectiveness of treatment options in this group of patients. J Psychiatr Res 41: 606–615. J Psychopharmacol 30: 495–553. Further contrast comparisons revealed that active dTMS was superior to sham at weeks 4 (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) and 6 (5.2; 95% CI 0.75 to 9.64, p=0.02) but not at other time points. Deng ZD, Lisanby SH, Peterchev AV (2013). Add-on high frequency deep transcranial magnetic stimulation (dTMS) to bilateral prefrontal cortex in depressive episodes of patients with major depressive disorder, bipolar disorder I, and major depressive with alcohol use disorders. Results were similar in the PP analyses (Table 2). We considered an adverse event to be present when it was of at least mild intensity, at least subjectively remotely associated with the intervention and reported in ⩾3 occasions (out of 8) and absent if otherwise. Electric field depth-focality tradeoff in transcranial magnetic stimulation: simulation comparison of 50 coil designs. Neuropsychopharmacology There was also a trend for greater response rates in the active (48%) vs sham (24%) groups. Iovieno N, Nierenberg AA, Parkin SR, Hyung Kim DJ, Walker RS, Fava M et al (2016). The coil is situated inside a helmet to achieve effective cooling during stimulation. Stevely A, Dimairo M, Todd S, Julious SA, Nicholl J, Hind D et al (2015). All clinical assessments were performed by a certified psychiatrist (DFT) and a certified psychologist (MLM) who are trained in the application of the structured questionnaires and interviews used in the present study. Three-dimensional distribution of the electric field induced in the brain by transcranial magnetic stimulation using figure-8 and deep H-coils. Berlim MT, van den Eynde F, Tovar-Perdomo S, Daskalakis ZJ (2014). Neuropsychopharmacol. Focus (Am Psychiatr Publ). Relationship between placebo response rate and clinical trial outcome in bipolar depression. Front Neurol 6: 16. Psychopharmacology and Experimental Therapeutics for Bipolar Depression. Tohen M, Frank E, Bowden CL, Colom F, Ghaemi SN, Yatham LN et al (2009). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Patients presented a median of 2 (IQR 2–4) previous depressive episodes. Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 4. Depress Anxiety 29: 587–596. Deep TMS Treatment for Bipolar Disorder. J Clin Psychiatry 71: 194–200. There were 2 dropouts in the sham group (both because of consecutive missing visits) and 5 dropouts in the active group (two were drop-outs for consecutive missing visits, two because of the severity of depressive symptoms and one because of side effects such as headache and burning sensation over the scalp), which was not statistically different (p=0.21; Figure 1). A secretary not directly participating in the research was responsible for handling the numbered cards to the staff before each session. ARB receives grants from the 2012 FAPESP Young Research Award from the São Paulo State Foundation (Grant no. The present randomized, sham-controlled trial showed that deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy. For comparative purposes, the National Institute of Clinical Excellence (NICE) states that a 3-point between group difference in HDRS scores translates into a clinically meaningful difference (Middleton et al, 2005). We enrolled 50 adults aging from 18 to 65 years old diagnosed with bipolar disorder types I or II in an acute depressive episode. The degree of confidence of active group allocation was, for raters, 52.17 (29.53) and 60 (31.46) in patients that received sham and active stimulation, respectively; while for patients it was 45.65 (30.46) and 53.57 (35.57), respectively. We also performed per protocol (PP) analyses. For the independent variables, we compared 1 predictor variable at a time and group. Before the screening interview, potential participants had their MT (the lowest stimulation intensity necessary to evoke a motor potential with at least 50 μV amplitude in 50% of attempts) assessed to determine eligibility. Young RC, Biggs JT, Ziegler VE, Meyer DA (1978). With TMS, a large electromagnetic coil is placed on a person’s forehead and short pulses are directed into an area of the brain believed to control moods. Clinical predictors associated with duration of repetitive transcranial magnetic stimulation treatment for remission in bipolar depression: a naturalistic study. The TMS sessions were delivered using the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). PubMed This work was primarily sponsored by Brainsway, which provided the dTMS devices and financial support. 20911-5), the Brain and Behavior research foundation (Grant Number 20493) and a National Council for Scientific and Technological Development Grant (CNPq, Grant no. Missing data were considered to be at random. McDonald WM, Durkalski V, Ball ER, Holtzheimer PE, Pavlicova M, Lisanby SH et al (2011). Goodwin GM, Haddad PM, Ferrier IN, Aronson JK, Barnes T, Cipriani A et al (2016). Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based treatment for major depressive disorder. US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs. National Library of Medicine Luborzewski A, Schubert F, Seifert F, Danker-Hopfe H, Brakemeier EL, Schlattmann P et al (2007). There were also a few patients (<10%) on aripiprazole, topiramate, olanzapine, risperidone, asenapine, carbamazepine, or ziprasidone. A sham coil is also included in the same helmet. Perlis RH, Ostacher MJ, Miklowitz DJ, Smoller JW, Dennehy EB, Cowperthwait C et al (2010). Secondary efficacy outcomes included response and remission status at week 4, depression improvement from baseline to week 8, and response and remission status at week 8. Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial Abstract. Maintenance deep transcranial magnetic stimulation sessions are associated with reduced depressive relapses in patients with unipolar or bipolar depression. In fact, as the H1-coil produces electrical fields that are relatively non-focal and deep (Deng et al, 2013), the stimulated brain area in our study was probably widespread beneath the coil. 2020 Oct 15;12(5):128-133. eCollection 2020. Other outcomes included HAM-A and CGI-S improvement. These effects were independent of anxiety levels or comorbidity. The median duration of the current depressive episode was 6 months (IQR 3–12). The subjects were stimulated every day for 4 weeks (except weekends). Nonetheless, negative results were also found in recent trials (Fitzgerald et al, 2016). Moreover, there are limited first-line therapies for treating bipolar depression (BD), treatment-resistance being two times higher compared to unipolar depression (Li et al, 2012; Tondo et al, 2014). Matsuda Y, Kito S, Igarashi Y, Shigeta M. Neuropsychobiology. The coil was positioned over the left dorsolateral prefrontal cortex, which was found 6 cm anteriorly to the ‘hot spot’ (ie, the optimal location on the scalp to evoke a maximum TMS response with minimum stimulator intensity), per a ruler attached to the subject’s cap. Epub 2020 Mar 27. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Tortella G, Sampaio-Junior B, Moreno ML, Moffa AH, da Silva AF, Lafer B, Lotufo PA, Gattaz W, Borrione L, Machado-Vieira R, Goerigk S, Benseñor IM, Brunoni AR. Remission rates were not statistically different. Bethesda, MD 20894, Copyright Standard repetitive transcranial magnetic stimulation (aka superficial transcranial magnetic stimulation), and deep transcranial magnetic stimulation, may be considered medically necessary when the criteria above are met. Grunze H, Vieta E, Goodwin GM, Bowden C, Licht RW, Moller HJ et al (2010). Other adverse events such as headache, neck pain, burning sensation, hearing complaints and concentration difficulties presented non-significantly different rates between groups (Supplementary Table 2). The International Society for Bipolar Disorders (ISBD) task force report on antidepressant use in bipolar disorders. Guy W ECDEU Assessment Manual for Psychopharmacology. However, we opted for stimulating the left DLPFC as low-frequency dTMS over the right DLPFC was not investigated for unipolar depression yet. Maintenance therapy is an important component of treatment in chronic bipolar and unipolar depression to reduce the risk for relapse or remission, and rTMS appears to have a potential … Although hypomania and mania episodes characterize the disorder, depressive episodes in fact exceed them in duration and frequency (Holtzman et al, 2015; Perich et al, 2016; Zimmerman, 2016). Article Holtzman JN, Lolich M, Ketter TA, Vazquez GH (2015). 2018 Apr 3;671:128-132. doi: 10.1016/j.neulet.2018.02.029. The number of failed treatments in the current episode was used to assess the degree of treatment-resistance. Frequency of TEMS and adverse events were compared among groups using Fisher’s exact test or the χ2 test. The system uses transcranial magnetic stimulation (TMS), a noninvasive form of neuromodulation, to stimulate areas of the brain that are underactive in depression. To verify blinding integrity, we asked, at week 8, for patients and raters to guess whether the allocation group was active on a 0–100 scale; guessing scores were compared using a t-test. In fact, a large randomized controlled trial showed that dTMS was effective and well-tolerated in depression treatment, with response and remission rates of, respectively, 38.4 and 32.6% (Levkovitz et al, 2015). Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Br J Psychiatry 133: 429–435. Our primary hypothesis was confirmed as active dTMS was superior to sham at the end of the acute treatment phase, with a mean difference in means of 4.88 in the HDRS. Int J Bipol Disor 3: 8. This study report conforms to CONSORT guidelines (Stevely et al, 2015). Scalp pain was the only adverse event more prevalent in active compared to sham dTMS. J Nerv Ment Dis 198: 679–681. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation therapy with established efficacy and acceptability for unipolar depression (George et al, 2010). J Psychiatr Res. BMJ 330: 267–268. These pulses are delivered through a magnetic coil … World J Biol Psychiatry 12: 119–126. Department and Institute of Psychiatry, Service of Interdisciplinary Neuromodulation (SIN-EMT), Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Diego F Tavares, Martin L Myczkowski, Rodrigo L Alberto, Leandro Valiengo, Rosa M Rios, Pedro Gordon, Bernardo de Sampaio-Junior, Izio Klein, Carlos G Mansur, Beny Lafer & André R Brunoni, Department and Institute of Psychiatry, Mood Disorders Unit (GRUDA), Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Department and Institute of Psychiatry, Laboratory of Neuroscience (LIM27), University of São Paulo, São Paulo, Brazil, Leandro Valiengo, Wagner Gattaz & André R Brunoni, University Hospital, University of São Paulo, São Paulo, Brazil, Bernardo de Sampaio-Junior, Izio Klein & André R Brunoni, Department and Institute of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Clarke Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada, You can also search for this author in Therefore, we conducted a randomized, sham-controlled clinical trial to evaluate the effectiveness and tolerability of deep-TMS as an add-on therapy to pharmacological treatment of resistant bipolar depressed patients. Levkovitz Y, Isserles M, Padberg F, Lisanby SH, Bystritsky A, Xia G et al (2015). Evid Based Ment Health 19: e16. Correspondence to 2019 Dec 10;19(1):319. doi: 10.1186/s12883-019-1531-z. (2021), Current Behavioral Neuroscience Reports and JavaScript. 2018 Aug 1;235:20-26. doi: 10.1016/j.jad.2018.04.022. A recent meta-analysis suggested that rTMS is effective in BD (McGirr et al, 2016). We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients.
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