MDDNCT06699940
A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents
An observational study of MDD, run by Neuronetics at 1 site in United States.
Trial summary
To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- MDD
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 7,690 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
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- a) Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.
- 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.
Who cannot join
- 1. Gap in NeuroStar Advanced Therapy treatment > 14 continuous days, where applicable.
- 2. More than one DLPFC treatment session on the same day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents
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.
- Conditions
- MDD
- Being tested
- Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Patients between the age of 12-21 received TMS treatment for MDD disorder.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Cohort | Patients in TrakStar database between the age of 12-21 who received at least one TMS treatment. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 May 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Cole, PhD, Study director, Neuronetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699940
- Sponsor's protocol ID
- 20226718
- Status last verified
- Jan 2025
- First submitted
- 19 Nov 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41367968
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents
- ClinicalTrials.gov ID
- NCT06699940
- Acronym / sponsor ID
- 20226718
- Conditions
- MDD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,690 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Cohort | – | Device: Transcranial Magnetic StimulationPatients in TrakStar database between the age of 12-21 who received at least one TMS treatment. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- 1. Gap in NeuroStar Advanced Therapy treatment > 14 continuous days, where applicable.
- 2. More than one DLPFC treatment session on the same day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationPatients between the age of 12-21 received TMS treatment for MDD disorder. | Device | Adolescent Cohort |
Primary outcome
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.
1 secondary outcome
Efficacy Outcome
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 41367968Croarkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Cole, PhD study director
Neuronetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDD, run by Neuronetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Outcome (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.