Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized trial with a crossover design will examine the efficacy of rTMS targeting the dorsomedial prefrontal cortex as a treatment for medication-resistant major depression in patients meeting diagnostic criteria for borderline personality disorder.
Patients meeting standard DSM-5 diagnostic criteria for borderline personality disorder, who also meet diagnostic criteria for a major depressive episode that has not responded to medication, will be eligible for inclusion. In a study with a randomized crossover design, they will undergo a course of either either active followed by sham or sham followed by active treatment. Each phase (active or sham) will involve 15 days of rTMS targeting the bilateral dorsomedial prefrontal cortex, 5x weekly, twice-daily with sessions 1 hour apart, using 20 Hz stimulation. Followup visits will occur at 1, 4, and 12 weeks after both courses of treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active -> Sham | Experimental | 15 days of active, followed by 15 days of sham rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold |
|
| Sham -> Active | Experimental | 15 days of sham, followed by 15 days of active rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsomedial prefrontal rTMS | Device | Active or sham rTMS targeting the dorsomedial prefrontal cortex, 20 Hz stimulation, 120% resting motor threshold, 1500 pulses per hemisphere, using a MagVenture R30 stimulator and Cool-DB80 coil. |
| Measure | Description | Time Frame |
|---|---|---|
| HRSD-17 change | The change in the 17-item Hamilton Rating Scale for Depression from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment | baseline to first followup (1 week post treatment), 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ZAN-BPD change | The change in the Zanarini Rating Scale for Borderline Personality Disorder from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment | baseline to first followup (1 week post treatment), 3 months post-treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Jonathan Downar, MD PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|