protocolSection identificationModule nctId: NCT06370988, orgStudyIdInfo id: 4343, briefTitle: Theta-Burst Stimulation for Bipolar Depression, acronym: TRIBE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, collaborators name: University Health Network, Toronto, descriptionModule briefSummary: The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion., conditionsModule conditions: Bipolar Depression, conditions: Bipolar Disorder, conditions: Treatment- Resistant Bipolar Disorder, conditions: Type 2 Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 A/P coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling, in which both the sham and active coils are contained internally. Its symmetric design ensures there is no indication of which side is active or sham with only the side of the coil delivering the treatment differing. The sham coil has been designed in such a way that it produces a similar auditory experience as the active coil. To account for the tactile sensation of active stimulation, both treatment allocations will have scalp electrodes placed that deliver a weak electrical stimulation to mask this tactile sensation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: iTBS Stimulation, interventions name: Sham iTBS Stimulation, outcomesModule primaryOutcomes measure: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), secondaryOutcomes measure: Symptoms of Mania, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, city: Toronto, state: Ontario, zip: M5T 2S8, country: Canada, contacts name: Eileen Lam, role: CONTACT, phone: 437-553-0367, email: Eileen.lam@uhn.ca, contacts name: Daphne Voineskos, M.D., Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centre for Addiction and Mental Health, city: Toronto, state: Ontario, zip: M6J 1H4, country: Canada, contacts name: Elizabeth Clancy, role: CONTACT, phone: 416-535-8501, phoneExt: 36434, email: Elizabeth.Clancy@camh.ca, contacts name: Tyler Kaster, M.D., Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False