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To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.
This is a retrospective analysis. The purpose of this study is to collate real world data (RWD) from existing medical records of patients aged 12 to 21 years who received treatment with NeuroStar Advanced Therapy for Major Depressive Disorder (MDD) as determined by scores on the PHQ-9 and CGI-S assessment tool into a central registry database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescent Cohort | Patients in TrakStar database between the age of 12-21 who received at least one TMS treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Patients between the age of 12-21 received TMS treatment for MDD disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome | To assess the pre-treatment to post-treatment change in PHQ-9 scores for the adolescent patient population. PHQ-9 is the Patient Health Questionnaire is a 9-question patient-completed assessment. Total scores range from 0 to 27. Higher the score means higher the depression severity. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome | To assess the pre-treatment to post-treatment change in CGI-S scores for the adolescent patient population. The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The total score range from 1 to 7 where 1 is normal and 7 is extremely ill patient. | 8 weeks |
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Inclusion Criteria:
Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-10 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins.
12 to 21 years of age.
Male or female.
Treatment with NeuroStar Advanced Therapy.
Treatment start-date of November 1, 2008, or later.
Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.
a) Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.
b) Intent-to-Treat (ITT) Subjects: Subject received at least one treatment with NeuroStar Advanced Therapy.
Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.
Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard per the current FDA clearance.
Each of GAD-7 and PHQ-9 scores available at each of pre-treatment (defined as the closest score available within 7 days prior to administration of the first treatment) and post-treatment (defined as the closest score available within ± 7 days of the date of the last treatment) evaluations for the single NeuroStar Advanced Therapy course.
Subjects with moderate or greater depression prior to NeuroStar Advanced Therapy (pre-treatment), defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10 within 7 days prior to the first treatment.
Exclusion Criteria:
- 1. Gap in NeuroStar Advanced Therapy treatment > 14 continuous days, where applicable.
2. More than one DLPFC treatment session on the same day.
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Patients between the age of 12-21 who were treated with NeuroStar Advanced Therapy for MDD on or after November 1, 2008 and the data was collected in TrakStar Database as standard of care practice
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| Name | Affiliation | Role |
|---|---|---|
| Eleanor Cole, PhD | Neuronetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuronetics | Malvern | Pennsylvania | 19355 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41367968 | Derived | Croarkin PE, Aaronson ST, Carpenter LL, Hutton TM, Pages K, Chen B, Sackeim HA. The Effectiveness of Transcranial Magnetic Stimulation in Adolescents and Young Adults With Major Depressive Disorder. JAACAP Open. 2025 Jul 1;3(4):1246-1258. doi: 10.1016/j.jaacop.2025.06.006. eCollection 2025 Dec. |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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