Retrospective TMS Therapy for Adults With MDD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder (MDD)

Intervention / Treatment
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* Device: TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female. At least 18 years of age. Treatment with NeuroStar TMS Therapy. Treatment date of November 01, 2008 or later. Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols. Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis. PHQ-9 scores available at baseline (pre-treatment). Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-20 TMS sessions<br>PHQ 9 ratings during this treatment period | Device: TMS<br>* Transcranial Magnetic Stimulation<br>|
| 21 - 29 TMS sessions<br>PHQ 9 ratings during this treatment period | Device: TMS<br>* Transcranial Magnetic Stimulation<br>|
| 30 TMS Sessions<br>PHQ 9 ratings during this treatment period | Device: TMS<br>* Transcranial Magnetic Stimulation<br>|
| 31-36 TMS Sessions<br>PHQ 9 ratings during this treatment period | Device: TMS<br>* Transcranial Magnetic Stimulation<br>|
| extended treatment 36 and beyond<br>PHQ 9 ratings during this treatment period | Device: TMS<br>* Transcranial Magnetic Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |