Major Depressive Disorder Clinical Trial
— ECaTaOfficial title:
Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre 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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | May 27, 2025 |
Est. primary completion date | April 27, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of delirium after electroconvulsive therapy over all (twelve) ECT sessions | The primary outcome is delirium after electroconvulsive therapy over all (twelve) ECT sessions. The presence of delirium will be assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU). To be able to perform the test correctly, the patient must be awake enough. This will be assessed using the Richmond-Agitation-Sedation-Scale (RASS) first ranging from -5 (unarousable) to +4 (combative) | 20 minutes after muscle relaxation | |
Secondary | Incidence of mild agitation | RASS +1, needing verbal command or short restraint < 1 minute | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Incidence of severe agitation | RASS > 1, needing restraint > 1 minute or rescue medication) | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Use of rescue medication | medication, dose, route | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Duration of seizure activity | seconds | during procedure (estimated to be on average 10-15 minutes) | |
Secondary | Quality of seizure activity | ideal, sufficient, insufficient | during procedure (estimated to be on average 10-15 minutes) | |
Secondary | Seizure Quality Index | Seizure Quality Index (Kranaster et al., Eur Arch Psychiatry Clin Neurosci 2018) ranging from 0 to 5. Higher index indicates better response to treatment. | during procedure (estimated to be on average 10-15 minutes) | |
Secondary | Need for seizure terminating medication | medication, dose, route | during procedure (estimated to be on average 10-15 minutes) | |
Secondary | Total number of electroconvulsive therapy sessions | number | whole treatment course (12 ECT sessions, about 4 weeks) | |
Secondary | Reason for terminating or continuing the electroconvulsive series | failure, response, remission, other reason | whole treatment course (12 ECT sessions, about 4 weeks) | |
Secondary | Length of post-anaesthesia care unit stay | minutes | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Incidence of desaturation | Oxygen saturation by pulse oximetry < 75%, irrespective of duration | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Incidence of hypotension | any measurement with mean arterial pressure < 55 mmHg | during procedure (estimated to be on average 10-15 minutes) | |
Secondary | Incidence of bradycardia | heart rate < 50 bpm for more than 1 minute | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Cardiovascular changes needing intervention | number and type | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Use of cardiovascular medication | medication, dose, route | post-anaesthesia care unit stay (up to 2 hours) | |
Secondary | Adverse events potentially attributable to ECT | diagnosis | whole treatment course (12 ECT sessions, about 4 weeks) | |
Secondary | Adverse events potentially attributable to Study Drug | diagnosis | whole treatment course (12 ECT sessions, about 4 weeks) |
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