Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

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).

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.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

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

  collaborator UNKNOWN

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• UT Health

  collaborator UNKNOWN

• Mclean Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of Utah

  collaborator OTHER

• UC San Francisco

  collaborator UNKNOWN

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Amit Anand, MD · Brigham and Woman's Hospital, Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2030-10-01

Completion

2030-12-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States
• Canada

Study Locations