Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called clonidine can help prevent agitation and confusion (called delirium) that some patients experience after undergoing electroconvulsive therapy (ECT) for serious mental health conditions like major depression and bipolar disorder. ECT is a useful treatment, but it can lead to these side effects in up to 65% of patients. The researchers believe that giving clonidine before the ECT procedure might reduce the chances of experiencing delirium, making the treatment safer and more manageable.

To participate in this study, you need to be at least 18 years old and scheduled for a series of outpatient ECT sessions at the University Hospital Bern. If you have certain health issues, are pregnant or breastfeeding, or are currently taking clonidine for other reasons, you may not be eligible. Participants will receive clonidine before their ECT sessions and will be monitored for any changes in their condition. This trial is currently recruiting, and if you think you might qualify, it’s a good idea to discuss it with your healthcare provider.

Gender

ALL

Eligibility 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.