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.
Must be deemed to have capacity to provide informed consent;
Must be an outpatient
Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);
Age 18-65;
have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
have a concomitant major unstable medical illness;
have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
are pregnant or intend to get pregnant during the study;
Parallel
iTBS Stimulation
DeviceFluid-Cooled B70 A/P Coil with either Magventure X100 or R30
Sham iTBS Stimulation
DeviceFluid-Cooled B70 A/P Coil with either Magventure X100 or R30
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), ITT, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
Symptoms of Mania
Safety of rTMS in BD-DE with respect to symptoms of mania, Young Mania Rating Scale (YMRS), Safety Outcomes, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
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Centre for Addiction and Mental Health
Lead sponsor
University Health Network, Toronto
Collaborator
