Life sciences · Interventional Study
ClinicalTrials.gov · October 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06370988). This is a study registration, not published results. Lead sponsor: Centre for Addiction and Mental Health. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 124 participants (ESTIMATED). Conditions: Bipolar Depression, Bipolar Disorder, Treatment- Resistant Bipolar Disorder, Type 2 Bipolar Disorder. Interventions: DEVICE: iTBS Stimulation; DEVICE: Sham iTBS Stimulation. Primary outcome measures: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) , From enrollment to 6 weeks post-treatment. Brief summary: 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.