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Completed

NCT Number: NCT06699940

A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

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

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Key information

Conditions

MDD

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuronetics

Malvern, Pennsylvania, 19355, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • More than one DLPFC treatment session on the same day.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Primary outcomes

  1. Efficacy Outcome

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Efficacy Outcome

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Neuronetics

Other

Registry information

Official study title

A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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