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
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated iTBS | Experimental | In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagPro X100 Stimulator, B70 Fluid-Cooled Coil | Device | Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) | Less than or equal to 10 | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HRSD-24 | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Response on HRSD-24 | 50% Reduction in score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Blumberger, MD | CAMH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAMH | Toronto | Ontario | M6J1H4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39443721 | Derived | Goodman MS, Trevizol AP, Konstantinou GN, Boivin-Lafleur D, Brender R, Downar J, Kaster TS, Knyahnytska Y, Vila-Rodriguez F, Voineskos D, Daskalakis ZJ, Blumberger DM. Extended course accelerated intermittent theta burst stimulation as a substitute for depressed patients needing electroconvulsive therapy. Neuropsychopharmacology. 2025 Mar;50(4):685-694. doi: 10.1038/s41386-024-02007-w. Epub 2024 Oct 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to 10 days (From screening/baseline to end of the acute treatment) |
| Remission on Patient Health Questionnaire (PHQ-9) | Less than or equal to 4 | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Response on PHQ-9 | 50% Reduction in score | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Change in PHQ-9 | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Remission on General Anxiety Disorder 7 item (GAD-7) | Less than or equal to 4 | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Response on GAD-7 | 50% Reduction in score | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Change in GAD-7 | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Remission on Beck Depression Inventory (BDI-II) | Less than or equal to 12 | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Response on BDI-II | 50% Reduction in Score | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Change on BDI-II | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Remission on Beck Scale for Suicidal Ideation (SSI) | Score of 0 | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Change on SSI | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Change in WHO Disability Assessment Schedule (WHODAS) | changes in scores | Up to 10 days (From screening/baseline to end of the acute treatment) |
| Proportion of Patients Maintaining Response During Relapse Prevention | Includes number of treatment days needed and number going on to receive ECT | 24 weeks (Tapering and Relapse prevention phase) |
| D001519 |
| Behavior |