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TITLE: Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression: Clinical-Effectiveness and Guidelines DATE: 14 April 2009 RESEARCH QUESTIONS: 1. What is the clinical-effectiveness of transcranial magnetic stimulation therapy for patients with refractory depression? 2. What are the guidelines for using transcranial magnetic stimulation therapy for patients with refractory depression? METHODS: A limited literature search was conducted on key health technology assessment resources, including PubMed, the Cochrane Library (Issue 1, 2009), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international HTA agencies, and a focused Internet search. Results include articles published between 2004 and April 2009, and are limited to English language publications only. No filters were applied to limit the retrieval by study type. Internet links are provided, where available. RESULTS: HTIS reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials (RCTs), controlled clinical trials, observational studies, and evidence-based guidelines. One health technology assessment, three systematic reviews, 13 RCTs, three controlled clinical trials, eight observational studies, and two evidence-based guidelines were identified pertaining to the use of transcranial magnetic stimulation therapy for patients with refractory depression. Additional information that may be of interest has been included in the appendix. Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. Health technology assessments 1. Repetitive transcranial magnetic stimulation as a treatment for major depression [technology assessment report]. Canberra, Australia: Medical Services Advisory Committee (MSAC); 2007. Summary available: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/2E0BACBB8704139ACA25 745E001C2F21/$File/1101%20- %20Repetitive%20transcranial%20magnetic%20stimulation%20Summary.pdf (accessed 09 Apr 2009) Full-text available: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/2E0BACBB8704139ACA25 745E001C2F21/$File/1101%20- %20Repetitive%20transcranial%20magnetic%20stimulation%20Report.pdf (accessed 09 Apr 2009) Systematic reviews and meta-analyses 2. Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med 2009;39(1):65-75. PubMed: PM18447962 3. Lam RW, Chan P, Wilkins-Ho M, Yatham LN. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry 2008;53(9):621-31. PubMed: PM18801225 4. Couturier JL. Efficacy of rapid-rate repetitive transcranial magnetic stimulation in the treatment of depression: a systematic review and meta-analysis. Journal of Psychiatry and Neuroscience 2005; 30(2): 83-90; 2009. Full-text available: http://www.cma.ca/multimedia/staticContent/HTML/N0/l2/jpn/vol-30/issue-2/pdf/pg83.pdf (accessed 09 Apr 2009) Structured abstract available with subscription at: http://www.cochrane.org Randomized controlled trials 5. Bares M, Kopecek M, Novak T, Stopkova P, Sos P, Kozeny J, et al. Low frequency (1-Hz), right prefrontal repetitive transcranial magnetic stimulation (rTMS) compared with venlafaxine ER in the treatment of resistant depression: A double-blind, single-centre, randomized study. J Affect Disord 2009. PubMed: PM19249105 6. Bretlau LG, Lunde M, Lindberg L, Unden M, Dissing S, Bech P. Repetitive transcranial magnetic stimulation (rTMS) in combination with escitalopram in patients with treatment- resistant major depression: a double-blind, randomised, sham-controlled trial. Pharmacopsychiatry 2008;41(2):41-7. PubMed: PM18311683 7. McLoughlin DM, Mogg A, Eranti S, Pluck G, Purvis R, Edwards D, et al. The Clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multicentre pragmatic randomised controlled trial and economic analysis. Health Technology Assessment 2007;11(24). Summary and full-text available: http://www.ncchta.org/execsumm/summ1124.shtml (accessed 14 Apr 2009) Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression 2 8. O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007;62(11):1208-16. PubMed: PM17573044 9. Avery DH, Holtzheimer PE, III, Fawaz W, Russo J, Neumaier J, Dunner DL, et al. A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biol Psychiatry 2006;59(2):187-94. PubMed: PM16139808 10. Fitzgerald PB, Huntsman S, Gunewardene R, Kulkarni J, Daskalakis ZJ. A randomized trial of low-frequency right-prefrontal-cortex transcranial magnetic stimulation as augmentation in treatment-resistant major depression. Int J Neuropsychopharmacol 2006;9(6):655-66. PubMed: PM16959055 11. Fitzgerald PB, Benitez J, de Castella A, Daskalakis ZJ, Brown TL, Kulkarni J. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry 2006;163(1):88-94. PubMed: PM16390894 12. McDonald WM, Easley K, Byrd EH, Holtzheimer P, Tuohy S, Woodard JL, et al. Combination rapid transcranial magnetic stimulation in treatment refractory depression. Neuropsychiatr Dis Treat 2006;2(1):85-94. 13. Rosa MA, Gattaz WF, Pascual-Leone A, Fregni F, Rosa MO, Rumi DO, et al. Comparison of repetitive transcranial magnetic stimulation and electroconvulsive therapy in unipolar non-psychotic refractory depression: a randomized, single-blind study. Int J Neuropsychopharmacol 2006;9(6):667-76. PubMed: PM16923322 14. Rossini D, Lucca A, Zanardi R, Magri L, Smeraldi E. Transcranial magnetic stimulation in treatment-resistant depressed patients: a double-blind, placebo-controlled trial. Psychiatry Res 2005;137(1-2):1-10. PubMed: PM16225930 15. Su TP, Huang CC, Wei IH. Add-on rTMS for medication-resistant depression: a randomized, double-blind, sham-controlled trial in Chinese patients. J Clin Psychiatry 2005;66(7):930-7. PubMed: PM16013911 16. Mosimann UP, Schmitt W, Greenberg BD, Kosel M, Muri RM, Berkhoff M, et al. Repetitive transcranial magnetic stimulation: a putative add-on treatment for major depression in elderly patients. Psychiatry Res 2004;126(2):123-33. PubMed: PM15123391 17. Poulet E, Brunelin J, Boeuve C, Lerond J, D'Amato T, Dalery J, et al. Repetitive transcranial magnetic stimulation does not potentiate antidepressant treatment. Eur Psychiatry 2004;19(6):382-3. PubMed: PM15363481 Controlled clinical trials 18. Vanderhasselt MA, De RR, Leyman L, Baeken C. Acute effects of repetitive transcranial magnetic stimulation on attentional control are related to antidepressant outcomes. J Psychiatry Neurosci 2009;34(2):119-26. PubMed: PM19270762 Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression 3 19. Loo CK, Mitchell PB, McFarquhar TF, Malhi GS, Sachdev PS. A sham-controlled trial of the efficacy and safety of twice-daily rTMS in major depression. Psychol Med 2007;37(3):341-9. PubMed: PM17176505 20. Kauffmann CD, Cheema MA, Miller BE. Slow right prefrontal transcranial magnetic stimulation as a treatment for medication-resistant depression: a double-blind, placebo- controlled study. Depress Anxiety 2004;19(1):59-62. PubMed: PM14978787 Observational studies 21. Cohen RB, Boggio PS, Fregni F. Risk factors for relapse after remission with repetitive transcranial magnetic stimulation for the treatment of depression. Depress Anxiety 2009. PubMed: PM19170101 22. Avery DH, Isenberg KE, Sampson SM, Janicak PG, Lisanby SH, Maixner DF, et al. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. J Clin Psychiatry 2008;69(3):441-51. PubMed: PM18294022 23. Bloch Y, Grisaru N, Harel EV, Beitler G, Faivel N, Ratzoni G, et al. Repetitive transcranial magnetic stimulation in the treatment of depression in adolescents: an open-label study. J ECT 2008;24(2):156-9. PubMed: PM18580562 24. Demirtas-Tatlidede A, Mechanic-Hamilton D, Press DZ, Pearlman C, Stern WM, Thall M, et al. An open-label, prospective study of repetitive transcranial magnetic stimulation (rTMS) in the long-term treatment of refractory depression: reproducibility and duration of the antidepressant effect in medication-free patients. J Clin Psychiatry 2008;69(6):930-4. PubMed: PM18505308 25. Abraham G, Milev R, Lazowski L, Jokic R, du TR, Lowe A. Repetitive transcranial magnetic stimulation for treatment of elderly patients with depression - an open label trial. Neuropsychiatr Dis Treat 2007;3(6):919-24. PubMed: PM19300628 26. Huang CC, Su TP, Wei IH. Repetitive transcranial magnetic stimulation for treating medication-resistant depression in Taiwan: a preliminary study. J Chin Med Assoc 2005;68(5):210-5. PubMed: PM15909725 27. Schulze-Rauschenbach SC, Harms U, Schlaepfer TE, Maier W, Falkai P, Wagner M. Distinctive neurocognitive effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in major depression. Br J Psychiatry 2005;186:410-6. PubMed: PM15863746 28. Nahas Z, Li X, Kozel FA, Mirzki D, Memon M, Miller K, et al. Safety and benefits of distance-adjusted prefrontal transcranial magnetic stimulation in depressed patients 55-75 years of age: a pilot study. Depress Anxiety 2004;19(4):249-56. PubMed: PM15274174 Guidelines and recommendations 29. Transcranial magnetic stimulation for severe depression [interventional procedure guidance 242]. London: National Institute for Health and Clinical Excellence (NICE); 2007. Available: http://www.nice.org.uk/nicemedia/pdf/IPG242GUIDANCE.pdf (accessed 09 Apr 2009) Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression 4 30. Major depression in adults in primary care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008. NGC summary available: http://www.guideline.gov/summary/pdf.aspx?doc_id=12617&stat=1&string=%22transcrani al+magnetic+stimulation%22 (accessed 09 Apr 2009) See page 44 Full guideline available: http://www.icsi.org/depression_5/depression__major__in_adults_in_primary_care_3.html (accessed 09 Apr 2009) PREPARED BY: Kristen Moulton, BA, Research Assistant Charlene Argáez, MLIS, Information Specialist Health Technology Inquiry Service Email: email@example.com Tel: 1-866-898-8439 Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression 5 APPENDIX – FURTHER INFORMATION: Randomized controlled trials 31. Turnier-Shea Y, Bruno R, Pridmore S. Daily and spaced treatment with transcranial magnetic stimulation in major depression: a pilot study. Aust N Z J Psychiatry 2006;40(9):759-63. PubMed: PM16911750 Consensus statements and clinical Policy 32. Transcranial magnetic stimulation and cranial electric stimulation [clinical policy bulletin no. 0469]. In: AETNA [website]. Hartford (CT): AETNA; 2008. Available: http://www.aetna.com/cpb/medical/data/400_499/0469.html (accessed 09 Apr 2009) 33. Consensus statement on depression in adults: how to improve prevention, diagnosis and treatment. Edmonton (AB): Institute of Health Economics; 2008. Available: http://www.ihe.ca/documents/Depression_Statement.pdf (accessed 09 Apr 2009) Transcranial Magnetic Stimulation Therapy for Patients with Refractory Depression 6
"Transcranial Magnetic Stimulation Therapy for Patients with "