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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugIV Ketamine 0.50 mg/kg
ECT
Procedure/SurgeryECT with unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Ketamine (HIKER)Experimental treatment 1 intervention
Group B: Ketamine-ECT (EAST)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of treatments required to reach disease remission
The primary outcome is number of treatments required to reach disease remission, as defined by a reduction of MADRS score to under 10
Time frame
From date of randomization until the date of disease remission or after 8 treatments, assessed up to 4 weeksSecondary outcomes
1
Rate of rescue ECT in the HIKER arm
Percent of patients in the HIKER arm who do not achieve a 25% reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) after the third treatment.
Time frame
From date of randomization up to 6 days2
Suicidal ideation
Suicidal ideation as measured by the Columbia Suicide Severity Rating Scale
Time frame
From date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks3
Cognitive Impairment
Cognitive Impairment as measured by Mini-Mental State Exam (MMSE)
Time frame
MMSE will be assessed at baseline, final treatment, and 30 day post-treatment follow-up4
Self- and clinician rated improvement
Patients will rate their condition on the patient-rated clinical global impression - improvement scale (PGI-I)
Time frame
From date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Saskatchewan
Lead sponsor
Royal University Hospital Foundation
Collaborator
Source ClinicalTrials.gov