RecruitingNot ApplicableNCT07147218

Accelerated TMS for MDD

Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder

Sponsor

Neuronetics

Enrollment

50 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

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

Eligibility

Min Age: 15 Years

Inclusion Criteria8

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

Exclusion Criteria12

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