RecruitingPhase 4NCT03272698

ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression

A Prospective Randomized Controlled Trial of Electroconvulsive Therapy with Ketamine Anesthesia (Standard Therapy) and High Intensity Ketamine with Electroconvulsive Therapy Rescue for Treatment-Resistant Depression - EAST HIKER Trial


Sponsor

University of Saskatchewan

Enrollment

62 participants

Start Date

Sep 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

To determine if an high intensity ketamine with ECT rescue (HIKER) approach for treatment resistant depression will: 1) reduce patient suffering by hastening disease remission, 2) have fewer side effects, 3) reduce the need for ECT, and 4) be preferred by most patients. Half of participants will be randomized to the HIKER arm and receive high intensity ketamine treatment for eight consecutive days, and the other half will be assigned to the ECT with ketamine anesthesia (EAST) arm and receive 8 ECT treatments (2-3 treatment/week)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for people with severe, treatment-resistant depression: electroconvulsive therapy (ECT, a procedure that uses brief electrical pulses to the brain) combined with standard anesthesia versus a high-intensity ketamine infusion regimen (with ECT available as a backup if needed). **You may be eligible if...** - You have severe depression (a high score on a standard depression scale) and are already scheduled to receive ECT - You have tried at least two different antidepressant medications that have not worked well enough **You may NOT be eligible if...** - You are unable to provide informed consent - You have a pacemaker, defibrillator, or other electronic implanted device - You have schizoaffective disorder - You are pregnant or refuse a pregnancy screening test - You have a known allergy to any of the study drugs - You have a serious heart, lung, brain, or blood pressure condition that makes ECT too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

IV Ketamine 0.50 mg/kg

PROCEDUREECT

ECT with unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method


Locations(1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada

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NCT03272698


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