RECRUITINGPhase 4INTERVENTIONAL

Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre Trial.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Aged 18 and more; - Scheduled for an elective series of ambulatory ECT sessions at the University Hospital Bern; - willing to sign a consent form as documented by signature (Appendix willing to sign a consent form Form). Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Clonidine

Clonidine 2mcg/kg Body Weight diluted in 100ml sodium chloride 0.9% compared to placebo (sodium chloride 0.9% alone) given over 10 minutes, 10 minutes prior to electroconvulsive therapy.

DRUG

Placebo

Sodium chloride 0.9% 100ml given over 10minutes, 10 minutes prior to electroconvulsive therapy.

Locations (1)

Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern

Bern, Switzerland