A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

NCT06699940 | Completed FDA Device

• 1 other identifier: 20226718
• Study Type: observational
• Target: 7,690
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MDD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Efficacy Outcome

  8 weeks

Study Arms (1)

Adolescent Cohort

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

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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

Adolescent Cohort

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- 1. Gap in NeuroStar Advanced Therapy treatment \> 14 continuous days, where applicable.
• \. More than one DLPFC treatment session on the same day.

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (1)

Neuronetics

Malvern, Pennsylvania, 19355, United States

Location

Related Publications (1)

• 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.

  PMID: 41367968 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eleanor Cole, PhD

  Neuronetics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)