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ENROLLING BY INVITATION
NCT06034821
PHASE4

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DEVICE

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