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| Name | Class |
|---|---|
| Southern California TMS Center | UNKNOWN |
| Brown University | OTHER |
| TMS of South Tampa | UNKNOWN |
| Sheppard Pratt Health System |
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Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.
The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-20 TMS sessions | PHQ 9 ratings during this treatment period |
| |
| 21 - 29 TMS sessions | PHQ 9 ratings during this treatment period |
| |
| 30 TMS Sessions | PHQ 9 ratings during this treatment period |
| |
| 31-36 TMS Sessions | PHQ 9 ratings during this treatment period |
| |
| extended treatment 36 and beyond | PHQ 9 ratings during this treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | Transcranial Magnetic Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | The primary objective of this study are to evaluate the changes in the Patient Health Questionnaire-9 (PHQ-9) total score. and the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline. | 1 to > 36 sessions for acute treatment sessions or > 6 weeks. |
| Primary Objective | The primary objective of this study are to evaluate the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline. | 1 to > 36 sessions for acute treatment sessions or > 6 weeks. |
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Inclusion Criteria:
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The study population comprises patients who were treated with Extended NeuroStar TMS Therapy for MDD on or after November 8, 2008, and whose treatment information was entered in the Neuronetics TrakStar registry at one of the qualifying participating study sites, and for whom the pre-specified required data elements are available in the TrakStar registry and who satisfy each of the study inclusion criteria and none of the exclusion criteria.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| Nashville NeuroCare Therapy | UNKNOWN |
| NAMSA | OTHER |
| Columbia University | OTHER |
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