Accelerated TMS for MDD

NCT07147218 | Recruiting FDA Device

• 1 other identifier: 11-10004-000
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (1)

• Change in PHQ-9 from baseline to post-treatment.

  2 weeks

Study Arms (1)

Treatment Arm

OTHER

Patients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments

Device: TMS

Interventions

TMS DEVICE

transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days

Treatment Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (3)

Brighter Neurotherapeutics

New York, New York, 10010, United States

RECRUITING

TMS of the Carolinas

Charlotte, North Carolina, 28210, United States

RECRUITING

New chapter TMS

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Eleanor Cole, PhD

  Neuronetics

  STUDY DIRECTOR

Central Study Contacts

Neha Goyal

CONTACT

7635281599; neha.goyal@neurostar.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: August 29, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (3)