The World Journal of Biological Psychiatry, 2014; 15: 167–168
LETTER TO THE EDITOR
Brain stimulation treatments for depression
World J Biol Psychiatry 2014.15:167-168. Downloaded from informahealthcare.com by McMaster University on 10/23/14. For personal use only.
MARK S. GEORGE1, THOMAS SCHLAEPFER2, FRANK PADBERG3 & PAUL B. FITZGERALD4 1Brain
Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA, of Psychiatry, University Hospital, Bonn, Germany, 3Psychiatry Department, University of Munich, Munich, Germany, and 4Monash Alfred Psychiatry Research Centre, Melbourne, Australia
2Department
Dear Editor, We read with some confusion and concern the recent WFSBP Guidelines for Biological Treatment of Unipolar Depressive Disorders published by the respective WFSBP Task Force. While the “Update 2013” is generally true to the title and an important clinical summary for the field, the sections regarding brain stimulation methods are in fact quite outdated and thereby likely to mislead readers. Their review and recommendations are in fact contradicted by the current recommendations of the WFSBP Taskforce on Brain Stimulation (Schlaepfer et al. 2010). For example, when discussing how to treat treatment-resistant patients, there is no mention of using transcranial magnetic stimulation (TMS) (see their Figure 3), which clearly has class I level of efficacy according to accepted review criteria. When discussing electroconvulsive therapy (ECT), there is no mention of the important recent advance with ultra brief unilateral stimulation, which is now the default method of ECT in many practices because of the decreased cognitive side effects with similar efficacy (Sackeim et al. 2008). The section on TMS appears particularly out of date. The authors reference one meta-analysis (Martin 2003) only and refer to it as “recent”. There have now been 13 meta-analyses, and new published study data in this field have fundamentally changed in the last decade. There have been large randomized controlled trials showing clear acute efficacy of TMS over sham and follow-up studies showing both reasonable size and durability of the effect (O’Reardon et al. 2007; George et al. 2010; McDonald et al. 2011; Carpenter et al. 2012; Mantovani et al. 2012).
All of these larger RCTs have taken place since the 2003 cited meta-analysis. There are now two manufacturers with FDA approval of their devices, based on pivotal multisite trial data. As of 2010, there were 89 different peer-reviewed published randomized controlled trials of TMS for depression. For ease of access they are listed in a downloadable spreadsheet maintained on the servers of the journal Brain Stimulation (Polley et al. 2011). We urge the authors to actually update this section of the guidelines, or acknowledge and refer readers to the WFSBP Brain Stimulation taskforce guidelines in this area, where experts with these new technologies have reached different conclusions (Schlaepfer et al. 2010). For example, with respect to TMS and depression, the 2010 WFSBP guidelines recommend, For the acute management of patients with moderately treatment resistant depression: There is sufficient class I evidence of acute efficacy for TMS in depression in medication-free unipolar depressed patients. The large body of evidence from single site small sample trials suggests that it may also be useful clinically in moderately treatment resistant patients, either alone or used adjunctively with medications. We thus recommend that psychiatrists consider using TMS in non-psychotic adults with major depression. Typically patients will have tried and failed at least one attempt at medication therapy, although this is not required … As rTMS efficacy data is continuing to emerge, the choice of stimulation parameters including frequency, laterality, intensity and duration of treatment will need to be determined by a psychiatrist familiar with the relevant and recent rTMS literature.
Correspondence: Mark S. George Medical University of South Carolina, Psychiatry, 502 N, IOP, 67 President St., Charleston, 29425 United States. E-mail: [email protected] (Received 30 September 2013; accepted 11 November 2013) ISSN 1562-2975 print/ISSN 1814-1412 online © 2014 Informa Healthcare DOI: 10.3109/15622975.2013.869619
168
M. S. George et al.
Sincerely, Mark S. George, MD Thomas Schlaepfer, MD Frank Padberg, MD Paul B. Fitzgerald, MBBS, PhD
Acknowledgements None.
World J Biol Psychiatry 2014.15:167-168. Downloaded from informahealthcare.com by McMaster University on 10/23/14. For personal use only.
Statement of Interest None to declare. References Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, et al. 2012. Transcranial magnetic stimulation (Tms) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety 29:587–96. George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, et al. 2010. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder:
a sham-controlled randomized trial. Arch Gen Psychiatry 67: 507–516. Mantovani A, Pavlicova M, Avery D, Nahas Z, McDonald WM, Wajdik CD, et al. 2012. Long-term efficacy of repeated daily prefrontal transcranial magnetic stimulation (Tms) in treatmnt-resistant depression. Depress Anxiety. Martin JL, Barbanoj MJ, Pérez V, Sacristán M. 2003. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev (3):CD003387. McDonald WM, Durkalski V, Ball ER, Holtzheimer PE, Pavlicova M, Lisanby SH, et al. 2011. Improving the antidepressant efficacy of transcranial magnetic stimulation: maximizing the number of stimulations and treatment location in treatment-resistant depression. Depress Anxiety 28:973–980. O’Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, et al. 2007. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 62:1208–1216. Polley KH, Navarro R, Avery DH, George MS, Holtzheimer PE. 2011. 2010 Updated Avery-George-Holtzheimer Database of rTMS depression studies. Brain Stimulation 4:115–116. Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, et al. 2008. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimulation 1:71–83. Schlaepfer TE, George MS, Mayberg H. 2010. WFSBP Guidelines on Brain Stimulation Treatments in Psychiatry. World J Biol Psychiatry 11:2–18.
LETTER TO THE EDITOR
Brain stimulation treatments for depression
World J Biol Psychiatry 2014.15:167-168. Downloaded from informahealthcare.com by McMaster University on 10/23/14. For personal use only.
MARK S. GEORGE1, THOMAS SCHLAEPFER2, FRANK PADBERG3 & PAUL B. FITZGERALD4 1Brain
Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA, of Psychiatry, University Hospital, Bonn, Germany, 3Psychiatry Department, University of Munich, Munich, Germany, and 4Monash Alfred Psychiatry Research Centre, Melbourne, Australia
2Department
Dear Editor, We read with some confusion and concern the recent WFSBP Guidelines for Biological Treatment of Unipolar Depressive Disorders published by the respective WFSBP Task Force. While the “Update 2013” is generally true to the title and an important clinical summary for the field, the sections regarding brain stimulation methods are in fact quite outdated and thereby likely to mislead readers. Their review and recommendations are in fact contradicted by the current recommendations of the WFSBP Taskforce on Brain Stimulation (Schlaepfer et al. 2010). For example, when discussing how to treat treatment-resistant patients, there is no mention of using transcranial magnetic stimulation (TMS) (see their Figure 3), which clearly has class I level of efficacy according to accepted review criteria. When discussing electroconvulsive therapy (ECT), there is no mention of the important recent advance with ultra brief unilateral stimulation, which is now the default method of ECT in many practices because of the decreased cognitive side effects with similar efficacy (Sackeim et al. 2008). The section on TMS appears particularly out of date. The authors reference one meta-analysis (Martin 2003) only and refer to it as “recent”. There have now been 13 meta-analyses, and new published study data in this field have fundamentally changed in the last decade. There have been large randomized controlled trials showing clear acute efficacy of TMS over sham and follow-up studies showing both reasonable size and durability of the effect (O’Reardon et al. 2007; George et al. 2010; McDonald et al. 2011; Carpenter et al. 2012; Mantovani et al. 2012).
All of these larger RCTs have taken place since the 2003 cited meta-analysis. There are now two manufacturers with FDA approval of their devices, based on pivotal multisite trial data. As of 2010, there were 89 different peer-reviewed published randomized controlled trials of TMS for depression. For ease of access they are listed in a downloadable spreadsheet maintained on the servers of the journal Brain Stimulation (Polley et al. 2011). We urge the authors to actually update this section of the guidelines, or acknowledge and refer readers to the WFSBP Brain Stimulation taskforce guidelines in this area, where experts with these new technologies have reached different conclusions (Schlaepfer et al. 2010). For example, with respect to TMS and depression, the 2010 WFSBP guidelines recommend, For the acute management of patients with moderately treatment resistant depression: There is sufficient class I evidence of acute efficacy for TMS in depression in medication-free unipolar depressed patients. The large body of evidence from single site small sample trials suggests that it may also be useful clinically in moderately treatment resistant patients, either alone or used adjunctively with medications. We thus recommend that psychiatrists consider using TMS in non-psychotic adults with major depression. Typically patients will have tried and failed at least one attempt at medication therapy, although this is not required … As rTMS efficacy data is continuing to emerge, the choice of stimulation parameters including frequency, laterality, intensity and duration of treatment will need to be determined by a psychiatrist familiar with the relevant and recent rTMS literature.
Correspondence: Mark S. George Medical University of South Carolina, Psychiatry, 502 N, IOP, 67 President St., Charleston, 29425 United States. E-mail: [email protected] (Received 30 September 2013; accepted 11 November 2013) ISSN 1562-2975 print/ISSN 1814-1412 online © 2014 Informa Healthcare DOI: 10.3109/15622975.2013.869619
168
M. S. George et al.
Sincerely, Mark S. George, MD Thomas Schlaepfer, MD Frank Padberg, MD Paul B. Fitzgerald, MBBS, PhD
Acknowledgements None.
World J Biol Psychiatry 2014.15:167-168. Downloaded from informahealthcare.com by McMaster University on 10/23/14. For personal use only.
Statement of Interest None to declare. References Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, et al. 2012. Transcranial magnetic stimulation (Tms) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety 29:587–96. George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, et al. 2010. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder:
a sham-controlled randomized trial. Arch Gen Psychiatry 67: 507–516. Mantovani A, Pavlicova M, Avery D, Nahas Z, McDonald WM, Wajdik CD, et al. 2012. Long-term efficacy of repeated daily prefrontal transcranial magnetic stimulation (Tms) in treatmnt-resistant depression. Depress Anxiety. Martin JL, Barbanoj MJ, Pérez V, Sacristán M. 2003. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev (3):CD003387. McDonald WM, Durkalski V, Ball ER, Holtzheimer PE, Pavlicova M, Lisanby SH, et al. 2011. Improving the antidepressant efficacy of transcranial magnetic stimulation: maximizing the number of stimulations and treatment location in treatment-resistant depression. Depress Anxiety 28:973–980. O’Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, et al. 2007. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 62:1208–1216. Polley KH, Navarro R, Avery DH, George MS, Holtzheimer PE. 2011. 2010 Updated Avery-George-Holtzheimer Database of rTMS depression studies. Brain Stimulation 4:115–116. Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, et al. 2008. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimulation 1:71–83. Schlaepfer TE, George MS, Mayberg H. 2010. WFSBP Guidelines on Brain Stimulation Treatments in Psychiatry. World J Biol Psychiatry 11:2–18.
