RECRUITINGPhase 4INTERVENTIONAL

ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression

A Prospective Randomized Controlled Trial of Electroconvulsive Therapy with Ketamine Anesthesia (Standard Therapy) and High Intensity Ketamine with Electroconvulsive Therapy Rescue for Treatment-Resistant Depression - EAST HIKER Trial

About This Trial

To determine if an high intensity ketamine with ECT rescue (HIKER) approach for treatment resistant depression will: 1) reduce patient suffering by hastening disease remission, 2) have fewer side effects, 3) reduce the need for ECT, and 4) be preferred by most patients. Half of participants will be randomized to the HIKER arm and receive high intensity ketamine treatment for eight consecutive days, and the other half will be assigned to the ECT with ketamine anesthesia (EAST) arm and receive 8 ECT treatments (2-3 treatment/week)

Who May Be Eligible (Plain English)

Who May Qualify: - Montgomery Asberg Depression Rating Scale (MADRS) score of greater than 20) planned for ECT therapy. - Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration. Who Should NOT Join This Trial: - Subjects will be ineligible if they cannot provide willing to sign a consent form - American Society of Anesthesiology physical status score of four or greater - Implanted medical device with electronic parts (e.g. pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, deep brain stimulator) - Schizoaffective disorder - Women of child-bearing potential will be asked to undergo a commercial urine pregnancy screening test. Those who refuse or screen positive will be excluded. - Allergic to any of the study drugs or their carrier components - Any serious physical condition prior to randomization deemed by the attending psychiatrist or consulting anesthetist to be a contraindication to ECT such as cardiovascular disease (including untreated hypertension), respiratory disease, cerebrovascular disease, intracranial hypertension (including glaucoma), or seizures. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Montgomery Asberg Depression Rating Scale (MADRS) score of greater than 20) planned for ECT therapy. * Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration. Exclusion Criteria: * Subjects will be ineligible if they cannot provide informed consent * American Society of Anesthesiology physical status score of four or greater * Implanted medical device with electronic parts (e.g. pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, deep brain stimulator) * Schizoaffective disorder * Women of child-bearing potential will be asked to undergo a commercial urine pregnancy screening test. Those who refuse or screen positive will be excluded. * Allergic to any of the study drugs or their carrier components * Any serious physical condition prior to randomization deemed by the attending psychiatrist or consulting anesthetist to be a contraindication to ECT such as cardiovascular disease (including untreated hypertension), respiratory disease, cerebrovascular disease, intracranial hypertension (including glaucoma), or seizures.

Treatments Being Tested

DRUG

Ketamine

IV Ketamine 0.50 mg/kg

PROCEDURE

ECT

ECT with unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method

Locations (1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada