Recruiting

ECT vs. Ketamine

Sponsor:

University of Saskatchewan

Code:

NCT03272698

Conditions

Treatment Resistant Depression

Ketamine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine

ECT

Study Details

Brief 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)

Conditions

Treatment Resistant Depression

Ketamine

Study ID

NCT03272698

Start date

Sep 1, 2017

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine (HIKER)

Patients in the HIKER arm will receive a single dose of ketamine 0.50 mg/kg, which is enough to achieve a full anaesthetic effect (i.e., unconsciousness mimicking the GA regimen above), on 8 successive weekdays.

active comparator: Ketamine-ECT (EAST)

Patients in the EAST arm will initially receive intravenous ketamine 0.75 mg/kg, remifentanil 1 mcg/kg (to reduce discomfort), and succinylcholine 0.75 mg/kg (for safety). Based on patients' anaesthetic response, the attending anaesthesiologist is given the freedom to vary the dose of remifentanil and succinylcholine as well as administer propofol to achieve safe and acceptable anaesthetic conditions. As per the Saskatoon Health Region's care standard, patients in the EAST arm will receive eight ECT sessions (on a bi/triweekly schedule) delivered by the attending psychiatrist with either unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method.

Interventions

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

Primary outcome measure

  • Number of treatments required to reach disease remission [ Time Frame: From date of randomization until the date of disease remission or after 8 treatments, assessed up to 4 weeks ]

Central Contacts and Locations

Central contacts

Una Goncin

3066551183ung039@usask.ca

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Stephen Lee, MD

3065010928stl960@mail.usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Jan 23, 2025

Last verified

Jan, 2025

Keywords

  • ketamine
  • treatment-resistant depression
  • electroconvulsive therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2025-01-23.