ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
NCT03272698 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2025-01-23
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 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
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Royal University Hospital Foundation
collaborator OTHER -
University of Saskatchewan
lead OTHER
Principal Investigators
-
Jonathan Gamble, MD · University of Saskatchewan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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