Using Clonidine to Reduce Delirium After Electroconvulsive Therapy
Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre Trial.
This study tests if giving clonidine before electroconvulsive therapy can help prevent delirium in patients with severe depression, bipolar disorder, or catatonia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04828226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of clonidine, an antihypertensive medication with sedative effects, to prevent postictal delirium in patients undergoing electroconvulsive therapy (ECT) for major depressive disorder, bipolar disorder, and catatonia. The study hypothesizes that administering clonidine prior to ECT will significantly lower the incidence of delirium, which can occur in up to 65% of patients after the procedure. Participants will be randomly assigned to receive either clonidine or a placebo before their ECT sessions. The trial aims to enhance the safety and accessibility of ECT for patients with refractory psychiatric illnesses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective ambulatory ECT sessions.
Not a fit: Patients with contraindications to clonidine, those undergoing emergency ECT, or individuals unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could make electroconvulsive therapy safer and more tolerable for patients, reducing the risk of postictal delirium.
How similar studies have performed: While the use of clonidine in this context is being explored, similar studies with dexmedetomidine have shown promise in reducing delirium, indicating potential for success with clonidine as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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 are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Where this trial is running
Bern
- Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Patrick Y Wüthrich, Prof, MD — Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern
- Study coordinator: Christian M Beilstein, MD
- Email: Christian.Beilstein@insel.ch
- Phone: +41 31 632 24 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.