Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (NCT03191058) | Clinical Trial Compass
CompletedNot Applicable
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression
United States, Canada239 participantsStarted 2018-06-26
Plain-language summary
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
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 a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
. are 18 years of age or older
. have a baseline HRSD-24 score \> or = 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;
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
Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)
Timeframe: Approximately 7 weeks
2
Worsening of Autobiographical Memory on the Autobiographical Memory Test (AMT)
Timeframe: Approximately 7 weeks
Trial details
NCT IDNCT03191058
SponsorUniversity of Texas Southwestern Medical Center
. are likely able to adhere to the intervention schedule;
Exclusion criteria
. 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);