Accelerated TMS for MDD

NCT ID: NCT07147218

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: OTHER

TMS

Intervention Type: DEVICE

transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days

Interventions

TMS

transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female

2. 15 years and older

3. Able to provide informed consent or/and assent

4. Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)

5. 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

6. Participant prescribed TMS Therapy to treat MDD by his or her physician independent of potential participation in this clinical study

7. 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

8. Willing to comply with all the study procedures, complete required assessments and visits, and be available for the duration of the study

Exclusion Criteria

1. Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI

2. Total MADRS score of < 20 or PHQ-score <10 at the screen or baseline visits

3. Current diagnosis of substance use disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence

4. Displaying symptoms of substance withdrawal

5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes

6. 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

7. Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results

8. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation

9. History of non-response to TMS or ECT

10. History of any implanted device or psychosurgery for depression

11. PI opinion: Considered at significant risk for suicide during the course of the study

12. 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuronetics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleanor Cole, PhD

Role: STUDY_DIRECTOR

Neuronetics

Locations

Brighter Neurotherapeutics

New York, New York, United States

Site Status: RECRUITING

TMS of the Carolinas

Charlotte, North Carolina, United States

Site Status: RECRUITING

New chapter TMS

Spokane, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Neha Goyal

Role: CONTACT

neha.goyal@neurostar.com

7635281599

Facility Contacts

Grant Brenner, MD

Role: primary

Terry Wise

Role: primary

Kiira Tietjen, DNP

Role: primary

Other Identifiers

11-10004-000

Identifier Type: -

Identifier Source: org_study_id