Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Poul Hansen Family Centre for Depression | UNKNOWN |
| Toronto Western Hospital, Canada | UNKNOWN |
| University Health Network, Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low frequency (1Hz) rTMS to the Right Dorsolateral Prefrontal Cortex | Experimental | Individuals will all receive 30 treatments of low frequency (1Hz) rTMS delivered to the Right Dorsolateral Prefrontal Cortex. rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagPro X100/R30 stimulator, Cool-B70 coil | Device | 1Hz rTMS delivered to the right DLPFC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) | Our primary analysis will be observational, and will calculate the change of the HRSD-17 score from baseline to completion of treatment (i.e., 6 weeks) as the primary outcome. Our primary analysis will be a student's paired t-test to compare the change from baseline to after 6 weeks of treatment with alpha set to 0.05. We will also report the standardized difference to determine the magnitude of change from baseline to completion of treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of hypomania/mania | Our secondary analysis will also be observational, and will calculate the change of the YMRS score from baseline to completion of treatment (i.e., 6 weeks) as a secondary outcome. Our primary analysis will be a student's paired t-test to compare the change from baseline to after 6 weeks of treatment with alpha set to 0.05. We will also report the standardized difference to determine the magnitude of change from baseline to completion of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Clancy | Contact | 416-535-8501 | 36434 | Elizabeth.Clancy@camh.ca |
| Mawahib Semeralul | Contact | 416-535-8501 | 30210 | mawahib.semeralul@camh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Tyler Kaster | CAMH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
No sharing of IPD, only de-identified. However, we are using ICES databases and not sure how this may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Single arm, open label trial to determine if 1Hz rTMS, delivered to the right DLPFC results in a significant reduction of depressive symptoms for individuals with a treatment-resistant bipolar disorder depressive episode (BD-DE) who have not previously responded in the TRIBE study (CTO#: 4343).
Not provided
Not provided
Not provided
Not provided
| 6 weeks |
| Centre For Addiction and Mental Health (CAMH) | Recruiting | Toronto | Ontario | M6J 1H1 | Canada |
|