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| Name | Class |
|---|---|
| Centre for Addiction and Mental Health | OTHER |
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This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | Treatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | The treatment will be delivered by trained medical personnel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe) | Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission. | Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe) | Outcome measured by a change in depression score from baseline (week prior to treatment) to 1 week and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 7 or less is categorized as remission. | Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Downar, MD, PhD | Contact | â€(647) 981-3951‬ | jonathan.downar@uhn.ca | |
| Eileen Lam | Contact | 416-603-5800 | 5494 | eileen.lam@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Downar | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36055538 | Derived | Sheen JZ, Miron JP, Mansouri F, Dunlop K, Russell T, Zhou R, Hyde M, Fox L, Voetterl H, Daskalakis ZJ, Griffiths JD, Blumberger DM, Downar J. Cardiovascular biomarkers of response to accelerated low frequency repetitive transcranial magnetic stimulation in major depression. J Affect Disord. 2022 Dec 1;318:167-174. doi: 10.1016/j.jad.2022.08.105. Epub 2022 Aug 31. | |
| 33581379 |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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prospective, single-arm, open label feasibility study
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| Miron JP, Voetterl H, Fox L, Hyde M, Mansouri F, Dees S, Zhou R, Sheen J, Desbeaumes Jodoin V, Mir-Moghtadaei A, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F, Downar J. Optimized repetitive transcranial magnetic stimulation techniques for the treatment of major depression: A proof of concept study. Psychiatry Res. 2021 Apr;298:113790. doi: 10.1016/j.psychres.2021.113790. Epub 2021 Feb 7. |