Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

October 1, 2030

Study Completion Date

December 1, 2030

Conditions
Acute Suicidal Depression (ASD)
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.

Trial Locations (11)

10029

Mount Sinai School of Medicine, New York

15213

University of Pittsburgh, Pittsburgh

21287

Johns Hopkins University, Baltimore

44195

Cleveland Clinic, Cleveland

63110

Washington University, St Louis

77030

Baylor College of Medicine, Houston

UTHealth Houston, Houston

85713

University of Arizona, Tucson

02478

McLean Hospital, Belmont

02114

Massachusetts General Hospital, Boston

M6J 1H4

Center for Addiction and Mental Health (University of Toronto), Toronto

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

University of Arizona

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

The Center for Addiction and Mental Health (University of Toronto)

UNKNOWN

collaborator

The University of Texas Health Science Center, Houston

OTHER

lead

Brigham and Women's Hospital

OTHER