Efficacy of Convulsive Therapies During Continuation (NCT03711019) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Convulsive Therapies During Continuation
Canada106 participantsStarted 2018-10-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Exclusion criteria
. have a concomitant major unstable medical illness;
. are pregnant or intend to get pregnant during the study;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in HRSD-24 Scores between MST and RUL-UB at 6 months
Timeframe: 6 months
2
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
. 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;