Background
Methods
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Technology Assessments: National Institute of Health and Clinical Excellence (NICE); Agency for Health Research and Quality (AHRQ); California Technology Assessment Forum (CTAF)/Institute for Clinical and Economic Review (ICER).
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Cochrane Database of Systematic Reviews
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Clinical consensus statements of specialty societies including the American Psychiatric Association and the Clinical TMS Society
Results
Electronic searches
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PubMed searched on January 20, 2018 using the search terms: ((((Predict*) AND response) AND rTMS)) AND depress* - 91 hits; 10 records obtained
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PubMed searched on January 31, 2018 using the search terms: ((((((rTMS) AND major) AND depress*) AND controlled) AND trial)) AND response – 85 hits; 6 records identified; 3 duplicates; 2 new record obtained.
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EBSCO searched on January 21, 2018 using the search terms: ((((Predict*) AND response) AND rTMS)) AND depress* - 59 hits; 4 records identified; 3 duplicates; 1 new record obtained
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EBSCO searched on January 31, 2018 using the search terms: ((((((rTMS) AND major) AND depress*) AND controlled) AND trial)) AND response – 50 hits; 4 records identified. 4 duplicates; 0 new records obtained.
Consensus recommendations by specialty societies
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American Psychiatric Association searched on January 20, 2018–1 hit; 1 record obtained
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Clinical TMS Society searched on January 20, 2018–1 hit; 1 record obtained
Technology assessments/systematic reviews
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National Institute for Health and Clinical Excellence (NICE) searched on January 22, 2018–1 hit; 1 record obtained
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Agency for Health Research and Quality (AHRQ) Technology Assessments searched on January 22, 2018–1 hit; 1 record obtained
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Cochrane Database of Systematic Reviews; searched on January 23, 2018–1 hit; 1 record obtained.
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California Technology Assessment Forum (CTAF) searched on February 1, 2018–1 hit; 1 record obtained.
Hand searches of reference sections of articles identified in above searches (searched on 1/23/18 & 1/31/18)
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Wang Y-M, et al. Randomized controlled trial of repetitive transcranial magnetic stimulation combined with paroxetine for the treatment of patients with first-episode major depressive disorder. Psych Research. 2017;254:18–23. 1 hit; 1 duplicate; 0 new records obtained.
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Wang H-N, et al. Clustered repetitive transcranial magnetic stimulation for the prevention of depressive relapse/recurrence: a randomized controlled trial. Trans Psych. 2017;7:1292. DOI https://doi.org/10.1038/s41398-0001-x. 1 hit; 1 new record obtained
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Huang M-L, et al. Repetitive transcranial magnetic stimulation in combination with citalopram in young patients with first-episode major depressive disorder: A double-blind, randomized sham-controlled trial. ANZJP. 2012;46(3):257–264. 2 hits; 2 duplicates; 0 new records found
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American Psychiatric Association. McClintock SM et al. Consensus recommendation for the clinical application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression. Journal Clinical Psychiatry. 2017; doi.org/10.4088/JCP.16cs10905–5 hits; 5 new records obtained
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Perera T, et al. The clinical TMS society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimulation. 2016;9:336–346. – 4 hits; 3 duplicates; 1 new record obtained.
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Beuzon G, et al. Predictors of response to repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder. Encephalie. 2017;43:3–9. 2 hits that were duplicates; 0 new records obtained.
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Dumas R, et al. Stimulation magnétique trancrânienne répétée dans la prise en chage des épisodes dépressifs majeurs: facteurs prédictifs de response thérapeutique. L’Encéphale 2012;38:360–368. 5 hits that were duplicates; 0 new records obtained.
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Brakemeier E-L, et al. Patterns of response to repetitive transcranial magnetic stimulation (rTMS) in major depression: Replication study in drug-free patients. Journal Affect Disord. 2008;108:59–70. 2 hits; 2 duplicates found. 0 new records obtained.
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Brakemeier E-L, et al. Positive predictors for antidepressive response to prefrontal repetitive transcranial magnetic stimulation (rTMS). 2007. 41:395–403. 2 hits; 1 duplicate. 1 new record obtained.
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Fregni, F et al. Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Inter Jrl Neuropsychopharm 2006;9:641–654. 1 hit; 1 new record found
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Carpenter LL, et al. Transcranial magnetic stimulation (TMS) for major depression: A multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety 2012;29:587–596. 2 hits; 2 duplicates. 0 new records found
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O’Reardon JP et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: A multisite randomized controlled trial. Biol. Psych. 2007;62:1208–1216. & Lisanby SH, et al. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: Clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharm. 2009;34:522–534. 3 hits; 3 duplicates. 0 new records found
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Mitchell PB, et al. Transcranial magnetic stimulation for depression. Austral New Zeal Jrl Psych. 2006;40:406–413. 0 hits
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Fitzgerald PB, et al. A study of the pattern of response to rTMS treatment in depression. Depress Anxiety. 2016;33:746–753. 4 hits; 2 duplicates. 2 new records obtained.
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Cohen RB, et al. Clinical predictors associated with duration of repetitive transcranial magnetic stimulation treatment for remission in bipolar depression. Jrl. Nerv Ment Disord. 2010;198:679–681. 1 hit; 1 duplicate. 0 new records found.
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Yang H, et al. A randomized controlled trial of right low frequency rTMS combined with escitalopram in treatment of patients with first-episode depression in general hospitals. JPBS. 2017;2(5):2. DOI: https://doi.org/10.20900/jpbs.20170016. 0 hits.
Study | Design | Baseline characteristics | Comparison # med trials (treatment resistance) | Outcome | CEBM/GRADE | |
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Fregni F, et al. Inter Jrl Neuropsychophar. 2006 [24] | Pooled data from 6 clinical trials – retrospective analysis Countries: Canada (N = 25 patients), US (N = 60), Austria (N = 29), Brazil (N = 21) | 153 patients; Age = 51.1 ± 15.1; M/F = 63/90 | ≥2 medication trials defined as refractory (medication resistant). | Treatment refractoriness was a significant predictor of clinical response to rTMS (P < 0.0001); use of Model 3 excluded Tel Aviv patients (N = 42) due to only one failed medication trial. Therefore 195–42 = 153 patients included in the analysis. | 1c/B | |
Brakemeier E-L, et al. Jrl. Psych Res. 2007 [30] | Prospective case series Country: Germany | 70 patients; Age = 49.5 ± 12.5; M/F = 44/26 | Comparison medication resistant (≥2 trials) (N = 51) to non-medication resistant (1 trial) (N = 19) | Patients with a shorter duration of depressive episode and lower level of medication resistance showed a greater response to rTMS. | 4/C | |
Double blind multisite (23 centers) RCT | 301 patients; Age = 48.3 ± 10.8; M/F = 142/159 | Comparison medication resistant (≥2 trials) (N = 147) to non-medication resistant (1 trial) (N = 164) | The likelihood of responding to rTMS was 4 times higher if patients had received one unsuccessful medication trial before rTMS in comparison with patients having received 2 or more unsuccessful trials (P = 0.021). Effect size in patients with one failed therapy was 0.83. Post hoc analysis performed by Lisanby. | 1b/B | ||
Countries: 20 sites US; 2 Austria; 1 Canada | ||||||
Brakemeier E-L, et al. Jrl Affect Disord. 2008 [31] | Prospective and retrospective case series Country: Germany | 79 patients; Age = 49.1 ± 14.3; M/F = 35/43 | Comparison within rTMS treatment arm medication resistant (≥2 trials) to non-medication resistant (1 trial) | Non-treatment resistant patients with a short duration of episode were more likely to respond to rTMS than medication resistant (43% vs. 18%) (P = 0.023) | 4/C | |
Cohen RB, et al. Jr. Nerv Ment Dis. 2010 [32] | Single center observation study Country: Brazil | 56 patients; Age = 48 ± 15; M/F = 26/30 | Comparison low treatment resistance [1 trial] (n = 34) to high treatment resistance [≥2 trials] (N = 22) | Low treatment resistance has a statistically significant effect (P < 0.01) on treatment outcome as measured by HDRS. | 4/C | |
Carpenter LL, et al. Depress Anxiety. 2012 [33] | Multicenter observational study Country: US | 307 patients; Age = 48.6 ± 14.2; M/F = 102/205 | Comparison low treatment resistance [≤1 trial] (n = 140) to high treatment resistance [≥2 trials] (N = 167) | Low treatment resistance had a modest influence on treatment outcome as measured by CGI-S and PHQ-9 outcomes. No statistical difference between groups on response and remission but a higher percentage of patients having response (59.4% vs. 56.8%; CGI-S; 57.2% vs. 55.6%; PHQ-9) or remission (39.9% vs. 34.9%; CGI-S; 31.9% vs. 26%; PHQ-9)with low treatment resistance | 4/C | |
Single center RCT Country: China | Active = 28; Age = 32.8 ± 7.3; M/F = 9/19 | Sham = 28; Age = 31.6 ± 7.4; M/F = 8/20 | Comparison of rTMS plus citalopram (N = 28) vs. rTMS sham plus citalopram (N = 28) in first episode major depressive disorder on response and remission after 4 weeks. First 2 weeks use of rTMS (active or sham). Second two week citalopram only in both groups. | Significantly greater number of early improvers (using HAMD-17) at 2 weeks with rTMS vs. sham/citalopram (P = 0.031). No difference in response (46% vs. 36%; P = 0.586) or remission (39% vs. 29%; P = 0.572) at 4 weeks. | 1b/B | |
Wang H-N, et al. Translational Psych. 2017 [27] | Single center RCT Country: China | rTMS+med = 82; Age = 42.3 ± 11.4;M/F = 22/60 | Med =108; Age = 40 ± 11.5; M/F = 23/85 | Comparison in first episode depressed patients: rTMS (N = 91) vs. antidepressant (N = 108) vs. rTMS plus antidepressant (N = 82) over 12 months. Examination of relapse/recurrence. | Relapse/recurrence at 12 months significantly lower in rTMS plus antidepressant group (20%) vs. antidepressant group (44.4%) (P = 0.033). | 1b/B |
Wang Y-M, et al. Psych Res. 2017 [28] | Single center RCT Country: China | Active = 22; Age = 28.8 ± 8.5; M/F = 12/10 | Sham = 23; Age = 30.1 ± 9.5; M/F = 13/10 | Comparison in treatment naïve patients rTMS plus paroxetine (N = 22) [active] to rTMS sham plus paroxetine (N = 21) [sham] | Response and remission rate of [active vs. sham] 95.5% vs. 71.4 and 68.2% and 38.1% respectively. (P < 0.05) | 1b/B |
Yang H, et al. Jrl Psych Brain Sci. 2017 [29] | Single center RCT Country: China | Active =41 patients; Age = 35.5 ± 12; M/F = 17/24 | Sham = 41 patients; Age = 35.4 ± 12.1; M/F = 15/25 | Comparison in treatment naïve patients rTMS plus escitalopram (N = 41) [active] to rTMS sham plus escitalopram (N = 41) [sham] | Active rTMS plus escitalopram significantly more effective (≥50% reduction in HAMD-17 score) (N = 36) than sham (N = 17) at 4 weeks (P < 0.05) | 1b/B |
Study | Reason excluded |
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Conca A, et al. Human Psychopharmacology. 2000 [44] | Did not examine effect of number of antidepressant trials on rTMS response |
Cochrane Review. 2001 [45] | Review 17 years old. Did not examine effect on the number of antidepressant trials on rTMS response. |
Holtzheimer PE, et al. Depression Anxiety. 2004 [46] | Patients treated with rTMS who responded/did not respond were identified as either having < 7 or > 7 antidepressant trials. |
Mitchell PB, et al. Austral New Zeal Jrl Psych. 2006 [34] | Descriptive review of 25 rTMS studies. Stated that patients who were more treatment resistant (resistance not defined) were less likely to respond to rTMS. |
CTAF, 2009 [47] | Review 8 years old. However did reference one study already included in assessement [18]. |
AHRQ. 2011 [35] | Did not examine number of failed medication trials effect on rTMS |
Aguirre AK, et al. Jrl Affective Disord. 2011 [48] | Age only was examined as a predictor of rTMS efficacy. |
Fitzgerald PB, et al. Expert Reviews 2011[49] | Stated patients were not treatment resistant. However, in examining paper, patients were found to have at least 2 failed medication trials. |
Connolly KR, et al. Jrl, Clinical Psych 2012 [40] | Jrl Clin Psych 2017 rTMS consensus recommendations [10] stated there was no relationship between degree of treatment resistance and response to rTMS in this study. However, in this case series analysis it was found that patients were had an average of 3.4 failed medication trials and were found to be treatment resistant - with no direct comparison group. |
NICE 2015 [36] | Did not examine number of failed medication trials effect on rTMS |
Levkovitz Y, et al. World Psych. 2015 [8] | Multicenter (20 centers) RCT. Countries: 14 sites US, 4 Israel, Germany, and 1 Canada. Total of 212 patients (ITT), 181 patients (Per protocol). Comparison low medication treatment resistance (≤2 trials) to ≥3 failed treatments. Patients treated with rTMS who failed ≤2 treatments significantly more responsive (P = 0.032) than those with ≥3 treatments (P = 0.057). |
Fitzgerald PB, et al. Depression Anxiety. 2016 [50] | Patients treated with rTMS who responded/did not respond had on average 5.7–6.1 failed medication trials. Could not break out low vs. high medication treatment resistance. |
Study | Reported adverse events |
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Fregni F, et al. Inter Jrl Neuropsychopharm. 2006 [24] | N = 54; Included headache, neck pain and scalp burn |
Brakemeier E-L, et al. Jrl. Psych Res. 2007 [30] | Not a defined endpoint. |
Active rTMS: eye pain (n = 10); GI & toothache (n = 12); site discomfort (n = 18); site pain (n = 59); facial pain (n = 11); muscle twitching (n = 334); pain of skin (n = 14). | |
Sham: eye pain (n = 3); GI & toothache (n = 1); site discomfort (n = 2); site pain (n = 6); facial pain (n = 5); muscle twitching (n = 5); pain of skin (n = 1) | |
Brakemeier E-L, et al. Jrl Affect Disord. 2008 [31] | Not a defined endpoint |
Cohen RB, et al. Jr. Nerv Ment Dis. 2010 [32] | Headache (n = 6); increased somnolence (n = 2); nightmares (n = 3) |
Carpenter LL, et al. Depress Anxiety. 2012 [33] | Tonic/clonic seizure (n = 1) |
Not a defined endpoint | |
Wang H-N, et al. Translational Psych. 2017 [27] | rTMS + meds: diarrhea (n = 5); constipation (n = 28); dry mouth (n = 43); nausea (n = 3); palpitations (n = 11); dizziness (n = 8); headache (n = 6); blurred vision (n = 21); tinnitus (n = 14). |
Meds: diarrhea (n = 8); constipation (n = 35); dry mouth (n = 66); nausea (n = 8); palpitations (n = 9); dizziness (n = 8); headache (n = 2); blurred vision (n = 15); tinnitus (n = 3). | |
Wang Y-M, et al. Psych Res. 2017 [28] | Active rTMS: headache/scalp pain (n = 7); Sham: headache/scalp pain (n = 8) |
Yang H, et al. Jrl Psych Brain Sci. 2017 [29] | Active rTMS: scalp pain & dizziness (n = 2) |
Number of medication trials | Studies | Comparator | Outcomes/effect; study duration |
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≥2 medication trials | Fregni F, et al. (2006) [24] | Higher response rate to rTMS therapy in patients who had a lower number of refractory treatment trials. | |
≤1 medication trial | Huang M-L, et al. (2012) [26]; | rTMS plus med vs. sham plus med | Significantly higher number of improvers at 4 weeks with rTMS plus med. |
Wang H-N, et al. (2017) [27]; | rTMS plus med vs. med | Significantly higher number in response and remission at 12 months with rTMS plus med. | |
Wang Y-M, et al. (2017) [28]; | rTMS plus med vs. sham plus med | Response and remission significantly higher in the rTMS + med | |
Yang H, et al. (2017) [29] | rTMS plus med vs. sham plus med | Response and remission significantly higher in the rTMS + med | |
≥2 medication trials vs. ≤1 medication trial | Brakemeier E-L, et al. (2007) [30]; | Use of rTMS with Low (1 trial) vs. high (≥2 trials) medication treatment resistance | Likelihood of response was higher in low treatment resistant patients |
O’Reardon JP, et al. (2009) [25]; | Use of rTMS with Low (1 trial) vs. high (≥2 trials) medication treatment resistance | Likelihood of response was 4X higher and statistically significantly different in low treatment resistant patients | |
Brakemeier E-L, et al. (2008) [31]; | Use of rTMS with Low (1 trial) vs. high (≥2 trials) medication treatment resistance | Use of rTMS in low treatment resistant patients had a statistically significant effect on improved outcomes | |
Cohen RB, et al. (2010) [32]; | Use of rTMS with Low (1 trial) vs. high (≥2 trials) medication treatment resistance | Use of rTMS in low treatment resistant patients had a statistically significant effect on improved outcomes | |
Carpenter LL, et al. (2012); [33] | Use of rTMS with Low (≤1 trial) vs. high (≥2 trials) medication treatment resistance | Use of rTMS in low treatment resistant patients had a modest effect on improving outcomes. |