ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Saskatchewan
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ketamine
- ECT
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Saskatchewan
Lead sponsor
Royal University Hospital Foundation
Collaborator
Source ClinicalTrials.gov