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Efficacy of Convulsive Therapies During Continuation (CORRECT-C)

Primary Purpose

Depression, Bipolar Depression, Unipolar Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic Seizure Therapy (MST)
RUL-UB ECT
Bitemporal ECT
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Magnetic Seizure Therapy, Electroconvulsive Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  1. are inpatients or outpatients;
  2. are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
  3. have met diagnostic criteria as assessed by MINI V6.0 in CREST-MST or CORRECT-BD
  4. are 18 years of age or older
  5. 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;
  6. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
  7. are agreeable to keeping their current antidepressant treatment constant during the intervention;
  8. are likely able to adhere to the intervention schedule;
  9. meet the MST safety criteria;
  10. 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:

  1. have a concomitant major unstable medical illness;
  2. are pregnant or intend to get pregnant during the study;
  3. have probable dementia based on study investigator assessment;
  4. 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;
  5. 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);
  6. 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;
  7. 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;
  8. are unable to communicate in English fluently enough to complete the neuropsychological tests;
  9. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)

Sites / Locations

  • UBC Hospital, University of British Columbia (UBC)Recruiting
  • Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental HealthRecruiting
  • Ontario Shores Centre for Mental Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Magnetic Seizure Therapy (MST)

RUL-UB ECT

Bitemporal ECT

Arm Description

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 12, 2018
Last Updated
June 29, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
University of British Columbia, Ontario Shores Centre for Mental Health Sciences, Brain Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03711019
Brief Title
Efficacy of Convulsive Therapies During Continuation
Acronym
CORRECT-C
Official Title
Cognitive Outcomes and the Response/Remission Efficacy of Convulsive Therapies During Continuation: CORRECT-C Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University of British Columbia, Ontario Shores Centre for Mental Health Sciences, Brain Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Depression, Unipolar Depression, Treatment Resistant Depression
Keywords
Magnetic Seizure Therapy, Electroconvulsive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Individuals blinded to their acute course of treatment will continue to receive the convulsive therapy to which they responded in in a blinded fashion.
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Seizure Therapy (MST)
Arm Type
Experimental
Arm Description
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Arm Title
RUL-UB ECT
Arm Type
Active Comparator
Arm Description
ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma
Arm Title
Bitemporal ECT
Arm Type
Active Comparator
Arm Description
ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma
Intervention Type
Device
Intervention Name(s)
Magnetic Seizure Therapy (MST)
Other Intervention Name(s)
MST
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
RUL-UB ECT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Bitemporal ECT
Other Intervention Name(s)
ECT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in HRSD-24 Scores between MST and RUL-UB at 6 months
Description
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.
Time Frame
6 months
Title
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Differences in relapse status between MST, RUL-UB ECT and bitemporal ECT
Description
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.
Time Frame
6 months
Title
Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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: 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; 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Blumberger, MD, MSc
Phone
416-535-8501
Ext
33662
Email
daniel.blumberger@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Taalman, MSc
Phone
416-535-8501
Ext
30990
Email
hannah.taalman@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD, MSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Hospital, University of British Columbia (UBC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T2A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fidel Vila-Rodriguez, MD, PhD
Phone
604-827-1361
Email
fidel.vilarodriguez@ubc.ca
First Name & Middle Initial & Last Name & Degree
Cathy Feng
Phone
(604)-822-7308
Email
cathy.feng@ubc.ca
Facility Name
Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD, MSc
Phone
416-535-8501
First Name & Middle Initial & Last Name & Degree
Hannah Taalman, MSc
Phone
416-535-8501
Ext
30990
Email
hannah.taalman@camh.ca
Facility Name
Ontario Shores Centre for Mental Health Sciences
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 5S9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Burhan, MD, MSc
Email
burhana@ontarioshores.ca
First Name & Middle Initial & Last Name & Degree
Mervin Blair
Email
blairmer@ontarioshores.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

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Efficacy of Convulsive Therapies During Continuation

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