Actively Recruiting
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
Led by University of Saskatchewan · Updated on 2025-01-23
62
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
Sponsors
U
University of Saskatchewan
Lead Sponsor
R
Royal University Hospital Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Montgomery Asberg Depression Rating Scale (MADRS) score greater than 20 and planned for ECT therapy
- Failure to respond to at least 2 standard-of-care drug therapies of adequate duration for treatment-resistant depression
You will not qualify if you...
- Unable to provide informed consent
- American Society of Anesthesiology physical status score of 4 or greater
- Implanted electronic medical device such as pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, or deep brain stimulator
- Diagnosis of schizoaffective disorder
- Women of child-bearing potential who refuse or test positive on pregnancy screening
- Allergy to study drugs or their carrier components
- Serious physical conditions deemed contraindications to ECT including cardiovascular disease (including untreated hypertension), respiratory disease, cerebrovascular disease, intracranial hypertension (including glaucoma), or seizures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
Research Team
U
Una Goncin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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