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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFL rTMS | Experimental | High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks |
|
| iTBS | Active Comparator | intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFL rTMS | Device | Magventure Cool B70 Coil with either RX100 or RX30 Stimulator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HAM-D17 score | Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission. | baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Blumberger, MD, MSc | Centre for Addiction and Mental Health | Principal Investigator |
| Jonathan Downar, MD, PhD | University Health Network, Toronto Western Hospital | Principal Investigator |
| Fidel Vila-Rodriguez, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Non-Invasive Neurostimulation Therapies Centre, University of British Columbia | Vancouver | British Columbia | V6T 2A1 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41245530 | Derived | Kaster TS, Dai Y, Vila-Rodriguez F, Downar J, Daskalakis ZJ, Blumberger DM, Rhee TG. Efficacy of intranasal esketamine versus rTMS for treatment-resistant depression: analysis of individual participant data from two clinical trials. EClinicalMedicine. 2025 Oct 30;90:103609. doi: 10.1016/j.eclinm.2025.103609. eCollection 2025 Dec. | |
| 36483268 |
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Individual patient level data will be shared once the investigators have completed all proposed analyses from the data set.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| iTBS |
| Device |
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator |
|
| Toronto Western Hospital |
| Toronto |
| Ontario |
| M5T 2S8 |
| Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
| Kaster TS, Downar J, Vila-Rodriguez F, Baribeau DA, Thorpe KE, Daskalakis ZJ, Blumberger DM. Differential symptom cluster responses to repetitive transcranial magnetic stimulation treatment in depression. EClinicalMedicine. 2022 Dec 2;55:101765. doi: 10.1016/j.eclinm.2022.101765. eCollection 2023 Jan. |
| 32382720 | Derived | Trevizol AP, Downar J, Vila-Rodriguez F, Thorpe KE, Daskalakis ZJ, Blumberger DM. Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial. EClinicalMedicine. 2020 Apr 30;22:100349. doi: 10.1016/j.eclinm.2020.100349. eCollection 2020 May. |
| 31668646 | Derived | Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18. |
| 31350213 | Derived | Hsu JH, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM. Impact of prior treatment on remission with intermittent theta burst versus high-frequency repetitive transcranial magnetic stimulation in treatment resistant depression. Brain Stimul. 2019 Nov-Dec;12(6):1553-1555. doi: 10.1016/j.brs.2019.07.011. Epub 2019 Jul 17. |
| 30764649 | Derived | Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15. |
| 30425640 | Derived | Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018. |
| 29726344 | Derived | Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. |
| D001519 |
| Behavior |