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| Name | Class |
|---|---|
| Brainsway | INDUSTRY |
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The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Deep TMS treatment |
|
| 2 | Sham Comparator | inactive stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-Coil deep TMS | Device | 20 daily deep rTMS treatments |
|
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| Measure | Description | Time Frame |
|---|---|---|
| change in the Hamilton depression rating scale score | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10. | 7 weeks |
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Inclusion Criteria:• Outpatients
Exclusion Criteria:• Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yechiel Levkovitz, MD | Contact | ylevk@clalit.org.il | ||
| Oded Meiron, PhD student | Contact | odedmei@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| shalvataMHC | Recruiting | Hod HaSharon | Israel |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| sham | Device | inactive treatment |
|
| D001519 |
| Behavior |