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Active, Not Recruiting

NCT Number: NCT07147218

Accelerated TMS for MDD

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brighter Neurotherapeutics, New York, United States

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About this study

This protocol will investigate the feasibility, tolerability and clinical efficacy of an accelerated TMS protocol delivering 36 sessions in 5 days

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

TMS

Device

transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Neuronetics

Other

Registry information

Official study title

Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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