- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641300
Efficacy of Convulsive Therapies for Bipolar Depression (CORRECT-BD)
Cognitive Outcomes and Response/Remission Efficacy of Convulsive Therapies for Bipolar Depression: The CORRECT-BD Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hannah Taalman, MSc
- Phone Number: 30990 4165358501
- Email: hannah.taalman@camh.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T2A1
- UBC Hospital, University of British Columbia (UBC)
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Ontario
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Toronto, Ontario, Canada, M6J 1H4
- Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
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Whitby, Ontario, Canada, L1N 5S9
- Ontario Shores Centre for Mental Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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;
- 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.
Exclusion Criteria:
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
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
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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.
Other Names:
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Active Comparator: Electroconvulsive Therapy (ECT)
ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24)
Time Frame: Greater than 8 treatments (2.5 weeks)
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Hamilton Rating Scale for Depression (24-item version):
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Greater than 8 treatments (2.5 weeks)
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Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Time Frame: Greater than 8 treatments (2.5 weeks)
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Autobiographical Memory Test: - Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity. |
Greater than 8 treatments (2.5 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)
Time Frame: 7 weeks
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Scale for Suicidal Ideation:
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7 weeks
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Number of self-reported and clinical-reported adverse events
Time Frame: Up to 7 weeks
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Number of adverse events in both treatment arms
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Up to 7 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel Blumberger, MD, MSc, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 015-2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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