Efficacy of Convulsive Therapies During Continuation

NCT03711019 | Completed

• 1 other identifier: 022-2018
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression; Bipolar Depression; Unipolar Depression; Treatment Resistant Depression

Keywords

Magnetic Seizure Therapy; Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (2)

• Differences in relapse status between MST, RUL-UB ECT and bitemporal ECT

  6 months

• Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT

  6 months

Study Arms (3)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

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

Device: Magnetic Seizure Therapy (MST)

RUL-UB ECT

ACTIVE COMPARATOR

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

Device: RUL-UB ECT

Bitemporal ECT

ACTIVE COMPARATOR

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

Device: Bitemporal ECT

Interventions

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.

Also known as: MST

Magnetic Seizure Therapy (MST)

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.

RUL-UB ECT

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.

Also known as: ECT

Bitemporal ECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of British Columbia: collaborator
• Ontario Shores Centre for Mental Health Sciences: collaborator
• Brain Canada: collaborator

Study Sites (3)

UBC Hospital, University of British Columbia (UBC)

Vancouver, British Columbia, V6T2A1, Canada

Location

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

MeSH Terms

Conditions

Depression; Bipolar Disorder; Depressive Disorder; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Daniel Blumberger, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Individuals blinded to their acute course of treatment will continue to receive the convulsive therapy to which they responded in in a blinded fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 18, 2018
• Study Start: October 22, 2018
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

CA (3)