Bipolar DisorderCORRECT-BDNCT03641300
Efficacy of Convulsive Therapies for Bipolar Depression
A study testing Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in people with Bipolar Disorder 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) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder
- What is being tested?
- Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesCanada
- Study dates
- 21 Sep 2018to 9 Aug 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
- Patients will be included if they:
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic Bipolar Disorder (Type I or II)
- are 18 years of age or older
- have a baseline HRSD-24 score > 21;
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- are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
- 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
- Patients will be excluded if they:
- have a history of MINI diagnosis of substance dependence or abuse within the past three months;
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have a MINI diagnosis of any primary psychotic disorder
- have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
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- 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;
- require a benzodiazepine with a dose greater than lorazepam 2 mg/day (or equivalent benzodiazepine) 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).
- These eligibility criteria are congruent with the criteria that have been used in the major ECT trials conducted during the past decade;
- elevated mood, defined as a score of 20 or higher on the Young Mania Rating Scale (YMRS).
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 Response/Remission Efficacy of Convulsive Therapies for Bipolar Depression: the CORRECT-BD Trial
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
Read the detailed description
The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in three academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, Ontario; the Ontario Shores Centre for Mental Health Sciences in Whitby, Ontario; and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators are pursuing a non-inferiority clinical trial in an effort to compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Depression symptoms will be assessed with the 24-item Hamilton Depression Rating Scale (HRSD-24) and suicidality will be assessed with the Scale for Suicidal Ideation (SSI). Remission will be defined as HRSD-24 < or = 10 and a > 60% decrease in scores from baseline on two consecutive ratings. Once a participant reaches remission, a second rating to confirm remission will be conducted immediately before their next scheduled treatment. If remission is confirmed, they will then be considered a completer of the acute treatment course. Remission of suicidal ideation is defined as a score of 0 on the SSI. Therefore, there will be no specific minimum number of treatments that patients must receive to be classified as remitters. However, patients who do not meet remission criteria after 21 treatment sessions will be considered non-remitters and will cease treatment sessions. This maximum treatment number was chosen allowing for the possibility that MST may require more treatment sessions to achieve remission, similar to RUL-UB ECT. The blind will not be broken to participants until the completion of the entire study.
- Being tested
- Magnetic Seizure Therapy (MST), Electroconvulsive Therapy (ECT)
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy, Bipolar Disorder, Depression, Suicidal Ideation
- Medical subject headings
- Bipolar Disorder, Depression, Suicidal Ideation
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. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
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.
Electroconvulsive Therapy (ECT)Device
Also called ECT
In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold 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) |
| Electroconvulsive Therapy (ECT) | Active comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24)
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)
Measured: Greater than 8 treatments (2.5 weeks)
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.
Measured: Greater than 8 treatments (2.5 weeks)
Secondary outcomes (2)
Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)
Scale for Suicidal Ideation:
- This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas
- Scale range: 0 - 38 (total score)
- Lower scores indicate lower severity of suicidal ideation (i.e., better outcome)
- Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)
Measured: 7 weeks
Number of self-reported and clinical-reported adverse events
Number of adverse events in both treatment arms
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Sep 2018
- Primary completion4 Mar 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 is a randomized, double blind, parallel-group clinical trial with two treatment arms conducted at three academic institutions: the Temerty Centre for Therapeutic Brain Intervention based at CAMH in Toronto, ON; the Ontario Shores Centre for Mental Health Sciences in Whitby, Ontario; and UBC Hospital based at the University of British Columbia in Vancouver, BC. CAMH aims to recruit 40 participants. Parkwood Institute and UBC Hospital aim to recruit 30 participants each.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 76 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
- NCT03641300
- Sponsor's protocol ID
- 015-2018
- Acronym
- CORRECT-BD
- Status last verified
- Nov 2024
- First submitted
- 17 Aug 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
PubMed 34131914
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 Response/Remission Efficacy of Convulsive Therapies for Bipolar Depression: the CORRECT-BD Trial
- ClinicalTrials.gov ID
- NCT03641300
- Acronym / sponsor ID
- CORRECT-BD / 015-2018
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy, Bipolar Disorder, Depression, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 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
- 21 Sep 2018 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 22 Aug 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) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
Detailed description
The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in three academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, Ontario; the Ontario Shores Centre for Mental Health Sciences in Whitby, Ontario; and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators are pursuing a non-inferiority clinical trial in an effort to compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Depression symptoms will be assessed with the 24-item Hamilton Depression Rating Scale (HRSD-24) and suicidality will be assessed with the Scale for Suicidal Ideation (SSI). Remission will be defined as HRSD-24 < or = 10 and a > 60% decrease in scores from baseline on two consecutive ratings. Once a participant reaches remission, a second rating to confirm remission will be conducted immediately before their next scheduled treatment. If remission is confirmed, they will then be considered a completer of the acute treatment course. Remission of suicidal ideation is defined as a score of 0 on the SSI. Therefore, there will be no specific minimum number of treatments that patients must receive to be classified as remitters. However, patients who do not meet remission criteria after 21 treatment sessions will be considered non-remitters and will cease treatment sessions. This maximum treatment number was chosen allowing for the possibility that MST may require more treatment sessions to achieve remission, similar to RUL-UB ECT. The blind will not be broken to participants until the completion of the entire study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, double blind, parallel-group clinical trial with two treatment arms conducted at three academic institutions: the Temerty Centre for Therapeutic Brain Intervention based at CAMH in Toronto, ON; the Ontario Shores Centre for Mental Health Sciences in Whitby, Ontario; and UBC Hospital based at the University of British Columbia in Vancouver, BC. CAMH aims to recruit 40 participants. Parkwood Institute and UBC Hospital aim to recruit 30 participants each.
| 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. |
| Electroconvulsive Therapy (ECT) | Active comparator | Device: Electroconvulsive Therapy (ECT)ECT 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 (11 listed)
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic Bipolar Disorder (Type I or II)
- are 18 years of age or older
- have a baseline HRSD-24 score > 21;
Key exclusion criteria (15 listed)
- have a history of MINI diagnosis of substance dependence or abuse within the past three months;
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have a MINI diagnosis of any primary psychotic disorder
- have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
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. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds). 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) |
| Electroconvulsive Therapy (ECT)Also: ECTIn the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes | Device | Electroconvulsive Therapy (ECT) |
Primary outcome
Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24)
Time frame: Greater than 8 treatments (2.5 weeks)
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)
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Time frame: Greater than 8 treatments (2.5 weeks)
Autobiographical Memory Test: - Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
2 secondary outcomes
Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)
Time frame: 7 weeks
Number of self-reported and clinical-reported adverse events
Time frame: Up to 7 weeks
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.
- Derived from this study: PubMed 34131914Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospitalLink provided by the sponsor.
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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) and Electroconvulsive Therapy (ECT) in people with Bipolar Disorder 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 11 inclusion and 15 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?
Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24) (time frame: Greater than 8 treatments (2.5 weeks)). 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?
On the ClinicalTrials.gov record for NCT03641300, which also lists 1 linked publication.
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.