CClinicalTrials.gg
CompletedNCT06699940Updated Jan 6, 2025

A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

An observational study in MDD, sponsored by Neuronetics. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Neuronetics · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
7,690
Ages
12 Years to 21 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • MDD
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In context

Lead sponsor

Neuronetics is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Retrospective
Enrollment
7,690 participants (actual)
Patient registry
No

Groups and cohorts

  • Adolescent Cohort

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

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

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

06

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

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Study locations

1 site
  • Neuronetics
    Malvern, Pennsylvania 19355, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06699940
Lead sponsor
Neuronetics
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
May 1, 2023
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Jan 6, 2025

Study contacts

Eleanor Cole, PhD
study director · Neuronetics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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