nctId: NCT06370988 id: 4343 briefTitle: Theta-Burst Stimulation for Bipolar Depression acronym: TRIBE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-04-17 date: 2024-04-22 name: Centre for Addiction and Mental Health class: OTHER name: University Health Network, Toronto 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. conditions: Bipolar Depression conditions: Bipolar Disorder conditions: Treatment- Resistant Bipolar Disorder conditions: Type 2 Bipolar Disorder studyType: INTERVENTIONAL phases: NA 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 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 count: 124 type: ESTIMATED name: iTBS Stimulation name: Sham iTBS Stimulation measure: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) measure: Symptoms of Mania sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Eileen Lam role: CONTACT phone: 437-553-0367 email: Eileen.lam@uhn.ca name: Daphne Voineskos, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre for Addiction and Mental Health city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Elizabeth Clancy role: CONTACT phone: 416-535-8501 phoneExt: 36434 email: Elizabeth.Clancy@camh.ca name: Tyler Kaster, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False