Major Depressive DisorderNCT07147218
Accelerated TMS for MDD
A study testing TMS in people with Major Depressive Disorder, run by Neuronetics at 3 sites in United States.
Trial summary
An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female
- 15 years and older
- Able to provide informed consent or/and assent
- Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)
- Adult participants failed to respond to at least one prior anti-depressant medication; for adolescent participants, TMS therapy is used as an adjunct treatment as stated in the FDA cleared indications, but failure to respond adequately to prior anti-depressant medication is not required
- Participant prescribed TMS Therapy to treat MDD by his or her physician independent of potential participation in this clinical study
- On a stable antidepressant treatment regimen (whether medication, therapy, other methods or no treatment at all) for at least the past 4 weeks and agrees to remain on the same treatment regimen throughout study enrollment
- Willing to comply with all the study procedures, complete required assessments and visits, and be available for the duration of the study
Who cannot join
- Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI
- Total MADRS score of < 20 or PHQ-score <10 at the screen or baseline visits
- Current diagnosis of substance use disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence
- Displaying symptoms of substance withdrawal
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes
- Any disorder which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening
Show all 12Show fewer
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
- History of non-response to TMS or ECT
- History of any implanted device or psychosurgery for depression
- PI opinion: Considered at significant risk for suicide during the course of the study
- Have any medical or psychological condition, that in the opinion of the referring psychiatrist or investigator, would prevent the participant from completing the study, put the participant at unacceptable risk or could interfere with study assessments or integrity of the data
Trial locations and contacts
3 sites in 1 country.
United States3 sites
TMS of the Carolinas
Charlotte, North Carolina, 28210
Brighter Neurotherapeutics
New York, New York, 10010
New chapter TMS
Spokane, Washington, 99202
About this study
Official title: Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder
An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).
Read the detailed description
This protocol will investigate the feasibility, tolerability and clinical efficacy of an accelerated TMS protocol delivering 36 sessions in 5 days
- Conditions
- Major Depressive Disorder
- Being tested
- TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Patients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS score from baseline to post-treatment.
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. Scores range from 0 to 60, with higher scores indicating greater severity
Measured: 2 weeks
Secondary outcomes (1)
Change in PHQ-9 from baseline to post-treatment.
The Patient Health Questionnaire-9 (PHQ-9) is a self-report questionnaire used to screen for depression scores range from 0-27 with higher scores indicating greater severity
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start21 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07147218
- Sponsor's protocol ID
- 11-10004-000
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07147218
- Acronym / sponsor ID
- 11-10004-000
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2025 (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.
An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).
Detailed description
This protocol will investigate the feasibility, tolerability and clinical efficacy of an accelerated TMS protocol delivering 36 sessions in 5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: TMSPatients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female
- 15 years and older
- Able to provide informed consent or/and assent
- Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)
- Adult participants failed to respond to at least one prior anti-depressant medication; for adolescent participants, TMS therapy is used as an adjunct treatment as stated in the FDA cleared indications, but failure to respond adequately to prior anti-depressant medication is not required
Key exclusion criteria (12 listed)
- Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI
- Total MADRS score of < 20 or PHQ-score <10 at the screen or baseline visits
- Current diagnosis of substance use disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence
- Displaying symptoms of substance withdrawal
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes
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 |
|---|---|---|
| TMStranscranial magnetic stimulation - DASH 36 treatment delivered in 5 days | Device | Treatment Arm |
Primary outcome
Change in MADRS score from baseline to post-treatment.
Time frame: 2 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. Scores range from 0 to 60, with higher scores indicating greater severity
1 secondary outcome
Change in PHQ-9 from baseline to post-treatment.
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Major Depressive Disorder, run by Neuronetics at 3 sites 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in MADRS score from baseline to post-treatment. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.