DepressionCORRECT-CNCT03711019
Efficacy of Convulsive Therapies During Continuation
A study testing Magnetic Seizure Therapy (MST), RUL-UB ECT and Bitemporal ECT in people with Depression and Bipolar Depression, run by Centre for Addiction and Mental Health at 3 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar Depression, Unipolar Depression
- What is being tested?
- Magnetic Seizure Therapy (MST), RUL-UB ECT and Bitemporal ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesCanada
- Study dates
- 22 Oct 2018to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have met diagnostic criteria as assessed by MINI V6.0 in CREST-MST or CORRECT-BD
- are 18 years of age or older
- achieve remission defined as HRSD-24 < 10 and a > 60% decrease in scores from baseline on two consecutive ratings OR achieve response on HRSD-24 defined as a 50% reduction in symptoms from baseline;
- are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
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- are agreeable to keeping their current antidepressant treatment constant during the intervention;
- are likely able to adhere to the intervention schedule;
- meet the MST safety criteria;
- If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.
Who cannot join
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have probable dementia based on study investigator assessment;
- have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
- present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
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- require a benzodiazepine with dose greater than lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
- are unable to communicate in English fluently enough to complete the neuropsychological tests;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
UBC Hospital, University of British Columbia (UBC)
Vancouver, British Columbia, V6T2A1
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, L1N 5S9
About this study
Official title: Cognitive Outcomes and the Response/Remission Efficacy of Convulsive Therapies During Continuation: CORRECT-C Trial
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.
Read the detailed description
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.
- Being tested
- Magnetic Seizure Therapy (MST), RUL-UB ECT, Bitemporal ECT
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy
- Medical subject headings
- Depression, Bipolar Disorder, Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Seizure Therapy (MST)Device
Also called MST
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.
RUL-UB ECTDevice
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.
Bitemporal ECTDevice
Also called ECT
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MST treatments will be administered using the MagPro MST with Cool TwinCoil. Receives: Device: Magnetic Seizure Therapy (MST) |
| RUL-UB ECT | Active comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma Receives: Device: RUL-UB ECT |
| Bitemporal ECT | Active comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma Receives: Device: Bitemporal ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in HRSD-24 Scores between MST and RUL-UB at 6 months
Hamilton Rating Scale for Depression (24-item version):
- This scale is used to quantify the severity of symptoms of depression
- Scale range: 0-76 (total score)
- Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
- Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
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.
Measured: 6 months
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Autobiographical Memory Test:
- Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
- The binary outcome is defined as a worsening of > 25% on the AMT total score.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT
Hamilton Rating Scale for Depression (24-item version):
- This scale is used to quantify the severity of symptoms of depression
- Scale range: 0-76 (total score)
- Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
- Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
A further endpoint will explore the difference on HRSD in those that receive MST, RUL-UB ECT and bitemporal ECT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start22 Oct 2018
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Ontario Shores Centre for Mental Health Sciences, Brain Canada
- Responsible party
- Principal investigator, Daniel Blumberger, Centre for Addiction and Mental Health
- Investigators
- Daniel Blumberger, MD, MSc, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711019
- Sponsor's protocol ID
- 022-2018
- Acronym
- CORRECT-C
- Status last verified
- Nov 2024
- First submitted
- 12 Oct 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Outcomes and the Response/Remission Efficacy of Convulsive Therapies During Continuation: CORRECT-C Trial
- ClinicalTrials.gov ID
- NCT03711019
- Acronym / sponsor ID
- CORRECT-C / 022-2018
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of British Columbia, Ontario Shores Centre for Mental Health Sciences, Brain Canada
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | Device: Magnetic Seizure Therapy (MST)MST treatments will be administered using the MagPro MST with Cool TwinCoil. |
| RUL-UB ECT | Active comparator | Device: RUL-UB ECTECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma |
| Bitemporal ECT | Active comparator | Device: Bitemporal ECTECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have met diagnostic criteria as assessed by MINI V6.0 in CREST-MST or CORRECT-BD
- are 18 years of age or older
- achieve remission defined as HRSD-24 < 10 and a > 60% decrease in scores from baseline on two consecutive ratings OR achieve response on HRSD-24 defined as a 50% reduction in symptoms from baseline;
Key exclusion criteria (9 listed)
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have probable dementia based on study investigator assessment;
- have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
- present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Seizure Therapy (MST)Also: MSTMST 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. | Device | Magnetic Seizure Therapy (MST) |
| RUL-UB ECTIn 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. | Device | RUL-UB ECT |
| Bitemporal ECTAlso: ECTBitemporal 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. | Device | Bitemporal ECT |
Primary outcome
Difference in HRSD-24 Scores between MST and RUL-UB at 6 months
Time frame: 6 months
Hamilton Rating Scale for Depression (24-item version): * This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) 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.
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Time frame: 6 months
Autobiographical Memory Test: * Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity. * The binary outcome is defined as a worsening of > 25% on the AMT total score.
2 secondary outcomes
Differences in relapse status between MST, RUL-UB ECT and bitemporal ECT
Time frame: 6 months
Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Blumberger, MD, MSc principal investigator
Centre for Addiction and Mental Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Seizure Therapy (MST), RUL-UB ECT and Bitemporal ECT in people with Depression and Bipolar Depression, run by Centre for Addiction and Mental Health at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in HRSD-24 Scores between MST and RUL-UB at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.