Clinical trial NCT06699940: A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents
Official title: A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MDD
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 7690
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Efficacy Outcome
timeFrame: 8 weeks
Secondary outcomes:
measure: Efficacy Outcome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Neuronetics
state: Pennsylvania
Study officials:
affiliation: Neuronetics
name: Eleanor Cole, PhD
role: STUDY_DIRECTOR
References: