ECT vs. Ketamine for Depression

(REaKT-SD Trial)

Recruiting at11 trial locations

Overseen by Amit Anand, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compares two treatments for patients with severe depression who are at risk of suicide. One treatment uses electric currents to change brain activity, while the other uses a low dose of a fast-acting drug. The goal is to find out which treatment works better for rapid relief. The drug has recently emerged as a fast-acting alternative for patients with treatment-resistant depression.

Research Team

Amit Anand, MD

Principal Investigator

Brigham and Woman's Hospital, Harvard Medical School

Eligibility Criteria

This trial is for adults aged 18-90 with acute suicidal depression who are candidates for ECT treatment. Participants must show ongoing suicidal thoughts and meet criteria for a major depressive episode, but not have schizophrenia or severe cognitive impairment. Pregnant individuals, those unable to consent, or with certain medical conditions like uncontrolled illness or ketamine allergy cannot join.

Inclusion Criteria

My doctor thinks I should get ECT treatment.

I am between 18 and 90 years old.

I have been diagnosed with a major depressive episode.

Exclusion Criteria

I am not eligible for ECT based on standard guidelines.

I cannot consent to ECT or KET treatment.

I am unable to understand or agree to the study's procedures and risks.

Treatment Details

Interventions

• Electroconvulsive therapy (ECT) (Electroconvulsive Therapy)
• Subanesthetic dose intravenous ketamine (KET) (NMDA Receptor Antagonist)

Trial Overview The study compares the effectiveness of Electroconvulsive therapy (ECT) versus intravenous Ketamine (KET) in treating acute suicidal depression. It's randomized and single-blind, meaning participants won't know which treatment they receive but researchers will.

Participant Groups

Group I: Electroconvulsive therapy (ECT) Active Control 1 Intervention

ECT will be given in a standard manner 3 times a week for 4 weeks.

Group II: Subanesthetic dose intravenous ketamine (KET) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

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

Collaborator

Trials

1

Recruited

1,500+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Allison Brown

University of Toronto

Chief Medical Officer

PhD in Chemical Engineering from the University of Toronto

Michael Sefton

University of Toronto

Chief Executive Officer since 2017

PhD in Chemical Engineering from the University of Toronto and MIT

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution