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The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison to a sham H-Coil rTMS in older patients with treatment-resistant major depressive disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute treatment phase will last four weeks. Treatment is administered daily, 5 days per week (i.e., 20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects achieve the pre-defined primary outcome criteria of remission (HDRS-24 score < 10 and 60% reduction in symptoms) they will continue with twice weekly treatment for two more weeks to ensure the durability of the remission. Subjects who do not achieve remission will exit the study after the acute treatment phase of four weeks. The blind will not be broken to subjects until the completion of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H coil DTMS | Experimental | 20 daily deep TMS treatments |
|
| inactive stimulation | Sham Comparator | 20 daily sham deep TMS treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H- Coil DTMS | Device | 20 daily deep rTMS treatments |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in depression symptoms, evaluated by HDRS | Clinical antidepressant response at the end of the treatment, define as a decline in Hamilton depression rating scale (HDRS-24) from the baseline rating by 50%. | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Remission in depression | 1. Clinical antidepressant remission at the end of the treatment, define as exit HDRS-24 <10 and 60% reduction in total score. | 6-8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yechiel Levkovich, M.D | Contact | ylevk@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| shalvataMHC | Hod HaSharon | Israel |
|
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Sham | Device |
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