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Clinical Trials in Canada / NCT03272698
Recruiting Phase 4

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

NCT03272698 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Saskatchewan
Phase
Phase 4
Started
2017-09-01
Last updated
2025-01-23

Condition(s) studied

Treatment Resistant DepressionKetamine

Investigational drug(s) / intervention(s)

Ketamine →ECT

Ketamine: IV Ketamine 0.50 mg/kg

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Montgomery Asberg Depression Rating Scale (MADRS) score of greater than 20) planned for ECT therapy. * Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration. Exclusion Criteria: * Subjects will be ineligible if they cannot provide informed consent * American Society of Anesthesiology physical status score of four or greater * Implanted medical device with electronic parts (e.g. pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, deep brain stimulator) * Schizoaffective disorder * Women of child-bearing potential will be asked to undergo a commercial urine pregnancy screening test. Those who refuse or screen positive will be excluded. * Allergic to any of the study drugs or their carrier components * Any serious physical condition prior to randomization deemed by the attending psychiatrist or consulting anesthetist to be a contraindication to ECT such as cardiovascular disease (including untreated hypertension), respiratory disease, cerebrovascular disease, intracranial hypertension (including glaucoma), or seizures.

Primary outcome measure(s)

  • Number of treatments required to reach disease remission — From date of randomization until the date of disease remission or after 8 treatments, assessed up to 4 weeks
    The primary outcome is number of treatments required to reach disease remission, as defined by a reduction of MADRS score to under 10

Trial sites (1)

FacilityCityRegionStatus
Royal University Hospital Saskatoon Saskatchewan Recruiting

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Other trials for the same condition

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Active, not recruiting
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST) Recruiting
Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression Starting soon
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA) Recruiting
Predictors of Intravenous Ketamine Response in TRD Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03272698 on ClinicalTrials.gov ↗ ← All trials in Canada