Ketamine Versus Electroconvulsive Therapy in Depression

Summary

While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Recent research shows that intravenous ketamine may be an alternative option for these patients due to its rapid antidepressant effect sustained with multiple treatments.

This study will recruit 240 participants from the ECT waiting list at the five participating hospitals, and randomize them to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5mg/kg ketamine intravenously (IV) over 40 minutes as described in the study schedule. Participants in the ECT treatment arm will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted.

The aim of this study is to show that compared to ECT, ketamine treatment produces faster results, has less side effects, requires less or shorter hospitalizations, and is less expensive. The measures collected throughout the study (clinician scales, self-reports, blood samples, and neuroimaging) may help with predicting if future patients will respond to ECT or ketamine. This could lead to faster, more effective treatment for patient with depression.

Conditions

• Depressive Disorder, Major
• Bipolar Depression

Interventions

DRUG

Intravenous Ketamine

Participants will receive 0.5mg/kg IV over 40 minutes, thrice weekly for 3 or 4 weeks. If participant responds, they will receive infusions weekly for one month, once every two weeks for two months, and once every month for three months. Should participant relapse during once monthly dosing, they may return to dosing once every two weeks for the remainder of the study.

PROCEDURE

Electroconvulsive Therapy

Participants will receive ECT treatment thrice weekly for the 3 or 4 weeks. If participant responds, they will continue to receive ECT, with frequency at the discretion of the treating physician based on best practice guidelines for the remainder of the study.

Sponsors & Collaborators

• McGill University

  collaborator OTHER

• Queen's University

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Ontario Shores Centre for Mental Health Sciences

  collaborator OTHER

• University of Ottawa

  lead OTHER

Principal Investigators

• Pierre Blier, MD, PhD · The Royal's Institute of Mental Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-29

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Canada

Study Locations