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The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS treatment | Experimental | Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
|
| Sham rTMS treatment | Sham Comparator | Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator | Device | The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity | Measured by the 24-item Hamilton Rating Scale for Depression | Baseline to four weeks (the conclusion of rTMS treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity | Measured by the 24-item Hamilton Rating Scale for Depression | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) |
| Clinically significant response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Stannard, BS, CCRP, CCRC | Cervel Neurotech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30306 | United States | ||
| Sheppard-Pratt Health System |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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|
| Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator | Device | The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils. |
|
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
| Baseline to four weeks (the conclusion of rTMS treatment) |
| Clinically significant response | Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) |
| Remission from depression | Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10 | Baseline to four weeks (the conclusion of rTMS treatment) |
| Remission from depression | Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10 | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) |
| Change in quality of life | Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form | Baseline to four weeks (the conclusion of rTMS treatment) |
| Change in quality of life | Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) |
| Incidence of treatment-emergent adverse events and serious adverse events | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) |
| Baltimore |
| Maryland |
| 21285 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| CRI Lifetree | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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