Accelerated TMS (36 sessions over 5 days) for major depression

Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder

This will try an accelerated TMS schedule—36 sessions delivered over 5 days—for people age 15 and older who are prescribed TMS for major depressive disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Neuronetics (Academic / other)
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT07147218 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, prospective protocol testing whether an accelerated transcranial magnetic stimulation (TMS) schedule is feasible, tolerable, and clinically effective. The intervention delivers 36 TMS sessions across five consecutive days at participating outpatient clinics. Adult participants generally must have failed at least one prior antidepressant, while adolescents may participate as an adjunct to other treatments per FDA-cleared indications. Participants must be prescribed TMS by their clinician and remain on a stable treatment regimen for at least four weeks during enrollment, with clinical ratings and safety/tolerability measures collected at baseline and follow-up.

Who should consider this trial

Good fit: Ideal candidates are people age 15 or older with a current major depressive episode who have been prescribed TMS by their clinician, with adults typically having failed at least one antidepressant and all participants on a stable treatment plan for four weeks.

Not a fit: Patients who are not prescribed TMS, have contraindications to TMS (such as certain implanted metal or an unmanaged seizure disorder), cannot tolerate an intensive daily schedule, or cannot attend five consecutive days of treatment are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could shorten treatment time and speed symptom improvement by delivering a full TMS course in one week, reducing time and travel burden for patients.

How similar studies have performed: Other small accelerated TMS protocols have reported promising rapid responses in pilot studies, but larger randomized trials and long-term data remain limited.

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

Where this trial is running

New York, New York and 2 other locations

• Brighter Neurotherapeutics — New York, New York, United States (Recruiting)
• TMS of the Carolinas — Charlotte, North Carolina, United States (Recruiting)
• New chapter TMS — Spokane, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Neha Goyal

Conditions Major Depressive Disorder