Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT07147218
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerated TMS for MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MADRS score from baseline to post-treatment.', 'timeFrame': '2 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in PHQ-9 from baseline to post-treatment.', 'timeFrame': '2 weeks', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).', 'detailedDescription': 'This protocol will investigate the feasibility, tolerability and clinical efficacy of an accelerated TMS protocol delivering 36 sessions in 5 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female\n2. 15 years and older\n3. Able to provide informed consent or/and assent\n4. Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)\n5. 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\n6. Participant prescribed TMS Therapy to treat MDD by his or her physician independent of potential participation in this clinical study\n7. 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\n8. Willing to comply with all the study procedures, complete required assessments and visits, and be available for the duration of the study\n\nExclusion Criteria:\n\n1. Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI\n2. Total MADRS score of \\< 20 or PHQ-score \\<10 at the screen or baseline visits\n3. Current diagnosis of substance use disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence\n4. Displaying symptoms of substance withdrawal\n5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes\n6. 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\n7. Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results\n8. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation\n9. History of non-response to TMS or ECT\n10. History of any implanted device or psychosurgery for depression\n11. PI opinion: Considered at significant risk for suicide during the course of the study\n12. 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'}, 'identificationModule': {'nctId': 'NCT07147218', 'briefTitle': 'Accelerated TMS for MDD', 'organization': {'class': 'OTHER', 'fullName': 'Neuronetics'}, 'officialTitle': 'Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder', 'orgStudyIdInfo': {'id': '11-10004-000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Arm', 'description': 'Patients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments', 'interventionNames': ['Device: TMS']}], 'interventions': [{'name': 'TMS', 'type': 'DEVICE', 'description': 'transcranial magnetic stimulation - DASH 36 treatment delivered in 5 days', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Grant Brenner, MD', 'role': 'CONTACT'}], 'facility': 'Brighter Neurotherapeutics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terry Wise', 'role': 'CONTACT'}], 'facility': 'TMS of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kiira Tietjen, DNP', 'role': 'CONTACT'}], 'facility': 'New chapter TMS', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'centralContacts': [{'name': 'Neha Goyal', 'role': 'CONTACT', 'email': 'neha.goyal@neurostar.com', 'phone': '7635281599'}], 'overallOfficials': [{'name': 'Eleanor Cole, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuronetics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuronetics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}