Major Depressive Disorder (MDD)
Conditions
Brief summary
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
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.
Interventions
DEVICETMS
Transcranial Magnetic Stimulation
Sponsors
Southern California TMS Center
Brown University
TMS of South Tampa
Sheppard Pratt Health System
Nashville NeuroCare Therapy
NAMSA
Columbia University
Neuronetics
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female. 2. At least 18 years of age. 3. Treatment with NeuroStar TMS Therapy. 4. Treatment date of November 01, 2008 or later. 5. Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols. 6. Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis. 7. PHQ-9 scores available at baseline (pre-treatment). 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 1 to > 36 sessions for acute treatment sessions or > 6 weeks. | 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. |
Outcome results
None listed