RECRUITING

Accelerated TMS for MDD

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder

Quick Facts

Study Start:2025-08-21

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07147218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Neha Goyal

CONTACT

7635281599

neha.goyal@neurostar.com

Principal Investigator

Eleanor Cole, PhD

STUDY_DIRECTOR

Neuronetics

Study Locations (Sites)

Brighter Neurotherapeutics

New York, New York, 10010

United States

New chapter TMS

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Neuronetics

Eleanor Cole, PhD, STUDY_DIRECTOR, Neuronetics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-21

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-08-21

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder