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This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-frequency rTMS | Experimental | 20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks |
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| Low-frequency rTMS | Experimental | 1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks |
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| Sham rTMS | Sham Comparator | Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-frequency rTMS | Device | 20 Hz active stimulation, twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| HAM-D17 score | Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission. | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment | |
| Beck anxiety inventory | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state functional MRI | 10 min resting-state functional MRI acquisition at 3T | 1 week pre- and 1 week post-intervention |
| Electroencephalography | 10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions |
Inclusion Criteria (Patient):
Exclusion Criteria (Patient):
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Downar, MD PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Low-frequency rTMS | Device | 1 Hz active stimulation, twice daily |
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| Sham rTMS | Device | Sham stimulation, twice daily |
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| Day 1 and day 15 (final day) of rTMS intervention |