Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study (NCT05054699) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study
Brazil100 participantsStarted 2021-05-31
Plain-language summary
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
Who can participate
Age range
18 Years – 65 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:
* Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria
* Score equal to or great than 17 points on the Hamilton Depression Rating Scale
* Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks
* Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist
Exclusion Criteria:
* Pregnancy
* Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency
* Depressive symptoms due to a clinical condition
* Any clinical or neurological conditions without proper management
* ECT or any other neuromodulation treatment on the last six months
* Inability to consent
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
Depressive symptoms
Timeframe: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
2
Biographical memory
Timeframe: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.