NCT03272698 ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
| NCT ID | NCT03272698 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Saskatchewan |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2017-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 62 participants in total. It began in 2017-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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.
Contact & Investigator
Jonathan Gamble, MD
PRINCIPAL INVESTIGATOR
University of Saskatchewan
Frequently Asked Questions
Who can join the NCT03272698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03272698 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03272698 currently recruiting?
Yes, NCT03272698 is actively recruiting participants. Contact the research team at ung039@usask.ca for enrollment information.
Where is the NCT03272698 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT03272698 clinical trial?
NCT03272698 is sponsored by University of Saskatchewan. The principal investigator is Jonathan Gamble, MD at University of Saskatchewan. The trial plans to enroll 62 participants.
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