A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

Neuronetics

Status: Completed

Conditions: MDD

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT06699940

20226718

Details and patient eligibility

About

To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.

Full description

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.

Enrollment: 7,690 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 12 to 21 years of age.

3. Male or female.

4. Treatment with NeuroStar Advanced Therapy.

5. Treatment start-date of November 1, 2008, or later.

6. Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.

7. 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.

8. Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.

9. Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard per the current FDA clearance.

10. 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.

11. 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.

Trial design

7,690 participants in 1 patient group

Adolescent Cohort

Description:

Patients in TrakStar database between the age of 12-21 who received at least one TMS treatment.

Treatment:

Device: Transcranial Magnetic Stimulation