protocolSection identificationModule nctId: NCT06357832, orgStudyIdInfo id: CTP-ACCiTBS-00, briefTitle: New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Brainsway, class: INDUSTRY, descriptionModule briefSummary: The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Brainsway Deep TMS System, outcomesModule primaryOutcomes measure: Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group, secondaryOutcomes measure: Response rate in the investigational group, secondaryOutcomes measure: Remission rate in the investigational group, secondaryOutcomes measure: Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group, secondaryOutcomes measure: Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novus Neurology, city: Tuscaloosa, state: Alabama, zip: 35401, country: United States, contacts name: Timothy Prestley, MD, role: CONTACT, phone: 205-523-5618, email: timprestley@gmail.com, geoPoint lat: 33.20984, lon: -87.56917, locations facility: DTMS Center LLC, city: Palm Beach, state: Florida, zip: 33401, country: United States, contacts name: Aron Tendler, MD, role: CONTACT, phone: 561-749-9999, email: aron.tendler@gmail.com, geoPoint lat: 26.70562, lon: -80.03643, locations facility: Fermata Health, city: Brooklyn, state: New York, zip: 11249, country: United States, contacts name: Owen Muir, MD, role: CONTACT, phone: 929-346-4317, email: owen@fermata.health, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Complete Mind Care of PA, city: Abington, state: Pennsylvania, zip: 19001, country: United States, contacts name: Samson Seplow, MD, role: CONTACT, phone: 215-254-6000, email: Dr.Seplow@cmcofpa.com, geoPoint lat: 40.12067, lon: -75.11795, locations facility: ClearPath Psychiatry, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Molly Davis, MD, role: CONTACT, phone: 206-486-8150, email: mollydavis@clearpathpsychiatry.com, geoPoint lat: 47.60621, lon: -122.33207, locations facility: PsyCare, city: South Charleston, state: West Virginia, zip: 25303, country: United States, geoPoint lat: 38.36843, lon: -81.69957, hasResults: False