CompletedPhase 4

Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Switzerland130 participantsStarted 2021-04-27

Plain-language summary

Electroconvulsive therapy (ECT) is a highly effective treatment for some psychiatric disorders like major depressive or bipolar disorder, but may lead to agitation and delirium after the procedure in up to 65% of patients. This can have negative side effects and be dangerous for patient and attending staff. Clonidine, a central-acting alpha2-receptor agonist, is an approved antihypertensive medication with known sedative side effects. Clonidine's newer but more expensive successor, dexmedetomidine, has recently shown its potential to reduce this kind of delirium. The investigators therefore hypothesise that pre-treatment with 2 mcg/kg clonidine prior to electroconvulsive therapy will significantly reduce the incidence of postictal delirium. This potentially makes a highly efficient treatment for patients with otherwise refractory psychiatric illness safer and more accessible.

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: * Aged 18 and more; * Scheduled for an elective series of ambulatory ECT sessions at the University Hospital Bern; * Informed Consent as documented by signature (Appendix Informed Consent Form). Exclusion Criteria: * Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block; * On regular Clonidine for another indication (e.g. arterial hypertension) * Patients undergoing emergency ECT; * Unable to consent (incapable of judgment, next-of-kin consent necessary or under tutelage); * Inability to follow the procedures of the study, e. g. due to language barrier; * Previous enrolment into the current study; * Participation in another study with investigational drug within the 30 days preceding and during the present study; * Enrolment of the investigator, his/her family members, employees and other dependent persons. * Women who are pregnant or breast feeding; * Intention to become pregnant during the course of the study; * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration (and 4 weeks thereafter), such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who…

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.

1This trial looked at using clonidine to prevent delirium after ECT — since it's a completed Phase 4 study, has the data been published, and what did it show about whether clonidine actually reduced delirium episodes across those twelve ECT sessions?
2Delirium after ECT can be a real concern — how common is post-seizure delirium in your experience with ECT patients, and is preventing it with a medication like clonidine something you'd consider for my treatment plan?
3Since clonidine is already an approved medication being studied here in a Phase 4 trial, can you explain what the known safety profile of clonidine looks like and whether its side effects — like lowering blood pressure — could be a concern given my specific health history?
4The trial tracked delirium over a full course of twelve ECT sessions — if I were to undergo ECT, is a twelve-session course typical for my diagnosis, and how would delirium prevention fit into managing my overall care during that period?
5Are there other strategies already in standard practice to reduce delirium after ECT that I should know about, and how does adding a medication like clonidine compare to those approaches?

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

Incidence of delirium after electroconvulsive therapy over all (twelve) ECT sessions

Timeframe: 20 minutes after muscle relaxation

Trial details

NCT IDNCT04828226

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-16

View on ClinicalTrials.gov More Major Depressive Disorder trials