Status:
RECRUITING
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Royal University Hospital Foundation
Conditions:
Treatment Resistant Depression
Ketamine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 effe...
Detailed Description
Major depressive disorder (MDD) is a common psychiatric illness that will affect at least 15% of the population. The burden of MDD is staggering, considered by the World Health Organization to be the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03272698
Start Date
September 1 2017
End Date
December 31 2025
Last Update
January 23 2025
Active Locations (1)
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1
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8