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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| Ontario Shores Centre for Mental Health Sciences | OTHER |
| Brain Canada | OTHER |
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This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) and two different forms of electroconvulsive therapy (ECT) in sustaining response during and after a course of continuation treatment.
The study will involve a parallel-group clinical trial with three treatment arms conducted at the Centre for Addiction and Mental Health (CAMH) in Toronto, ON, Ontario Shores Centre for Mental Health Sciences in Whitby, ON and University of British Columbia (UBC) Hospital in Vancouver, BC. It will include participants who are classified as responders or remitters in the CREST-MST (NCT03191058) trial, the CORRECT-BD (NCT03641300) trial and individuals responding to bitemporal ECT after participating in either of the above trials, who qualify for a continuation course of convulsive therapy to prevent relapse of depression. Individuals blinded to their acute course of treatment will continue to receive the convulsive therapy to which they responded in in a blinded fashion. Continuation treatments will be scheduled according to a modified version of the Symptom-Titrated Algorithm-based Longitudinal ECT (STABLE) algorithm. STABLE includes an initial four week period of ECT delivered on a fixed schedule (once or twice per week), and then transitions to a symptom-driven schedule whereby ECT is delivered between zero and two times per week based on the patient's weekly Hamilton Rating Scale for Depression (HRSD-24) outcomes during weeks five to 24.
Further, this trial will also include non-responders to MST or right unilateral ultrabrief pulse ECT (RUL-UB ECT) from CREST-MST or CORRECT-BD, who are switched to bitemporal ECT based on their clinical indication. They will receive bitemporal ECT on an acute basis, i.e. 2 - 3 times per week. If their symptoms respond or remit with bitemporal ECT, they will also be offered a continuation course of bitemporal ECT as part of this trial and will be followed in the same manner as those receiving MST or RUL-UB ECT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MST treatments will be administered using the MagPro MST with Cool TwinCoil. |
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| RUL-UB ECT | Active Comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma |
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| Bitemporal ECT | Active Comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Seizure Therapy (MST) | Device | MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. Seizure threshold will have been determined during the first treatment session following a standard established protocol in the context of CREST-MST or CORRECT-BD. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase. This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in HRSD-24 Scores between MST and RUL-UB at 6 months | Hamilton Rating Scale for Depression (24-item version):
Non-inferiority trials such as this proposed study specify a non-inferiority margin, with a tolerance of 3.9 points denoting equivalence between the two treatments when the efficacy of MST can be concluded to be not more than 3.9 points on the HRSD-24 at the endpoint of treatment. | 6 months |
| Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) | Autobiographical Memory Test:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in relapse status between MST, RUL-UB ECT and bitemporal ECT | The secondary exploratory endpoint will investigate the differences between MST, RUL-UB ECT and bitemporal ECT on relapse status among participants during and after a course of continuation convulsive therapy. | 6 months |
| Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT |
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Participants in the Acute Phase (bitemporal ECT) will have already met the diagnostic criteria and severity eligibility criteria specified in the protocols of CREST-MST and CORRECT-BD.
At the time of recruitment, participants in the Continuation Phase (MST, RUL-UB ECT, Bitemporal ECT) will meet the following eligibility criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Blumberger, MD, MSc | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBC Hospital, University of British Columbia (UBC) | Vancouver | British Columbia | V6T2A1 | Canada | ||
| Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health |
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| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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The study will involve a parallel-group clinical trial with three treatment arms conducted at the Centre for Addiction and Mental Health (CAMH) in Toronto, ON, Ontario Shores Centre for Mental Health Sciences in Whitby, ON and UBC Hospital in Vancouver, BC.
The investigators plan to enroll up to 105 participants to ensure 70 participants receive a complete course of continuation therapy following MST, RUL-UB ECT, or bitemporal ECT and anticipate enrolling up to 60 participants who will receive an acute course of bitemporal ECT as part of our secondary exploratory outcome over 48 months.
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Individuals blinded to their acute course of treatment will continue to receive the convulsive therapy to which they responded in in a blinded fashion.
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| RUL-UB ECT | Device | In the RUL-UB ECT arm treatment, the MECTA spectrum 5000Q or MECTA Sigma machine will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. Seizure threshold will have been determined during the first treatment session following a standard established protocol in the context of CREST-MST or CORRECT-BD. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase. This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes. |
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| Bitemporal ECT | Device | Bitemporal ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. Bitemporal ECT will be administered at 1.5 times seizure threshold according to standard clinical practice. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase. This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes. |
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Hamilton Rating Scale for Depression (24-item version):
A further endpoint will explore the difference on HRSD in those that receive MST, RUL-UB ECT and bitemporal ECT. |
| 6 months |
| Toronto |
| Ontario |
| M6J 1H4 |
| Canada |
| Ontario Shores Centre for Mental Health Sciences | Whitby | Ontario | L1N 5S9 | Canada |
| D001523 |
| Mental Disorders |