Status:
RECRUITING
Clonidine to Prevent Delirium After Electroconvulsive Therapy.
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Conditions:
Major Depressive Disorder
Catatonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Electroconvulsive therapy (ECT) is a highly efficacious therapy for psychiatric disorders, especially major depressive disorder, bipolar disorder and catatonia resistant to psychopharmacology or drug-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04828226
Start Date
April 27 2021
End Date
July 31 2026
Last Update
August 6 2025
Active Locations (1)
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1
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern
Bern, Switzerland, 3010