A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

NCT ID: NCT06699940

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7690 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-05-01

Brief Summary

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

Detailed 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.

Conditions

MDD

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adolescent Cohort

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

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Patients between the age of 12-21 received TMS treatment for MDD disorder.

Interventions

Transcranial Magnetic Stimulation

Patients between the age of 12-21 received TMS treatment for MDD disorder.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuronetics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleanor Cole, PhD

Role: STUDY_DIRECTOR

Neuronetics

Locations

Neuronetics

Malvern, Pennsylvania, United States

Countries

United States

Other Identifiers

20226718

Identifier Type: -

Identifier Source: org_study_id