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Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan
Sponsor: Brigham and Women's Hospital
Summary
This study is a randomized open-label single-blind non-inferiority comparative effectiveness study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).
Official title: Rapid Reversal of Suicidal Depression: Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan (REaKT-SD)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2023-10-01
Completion Date
2030-12-01
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Subanesthetic dose intravenous ketamine (KET)
This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.
Electroconvulsive therapy (ECT)
ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.
Locations (10)
UC San Francisco
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai School of Medicine
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
UTHealth Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Center for Addiction and Mental Health (University of Toronto)
Toronto, Ontario, Canada