Comparing high intensity ketamine with ECT versus ECT with ketamine anesthesia 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
This study is testing if a new high intensity ketamine treatment combined with ECT can help people with treatment-resistant depression feel better faster and with fewer side effects compared to traditional ECT with ketamine anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Locations | 1 site (Saskatoon, Saskatchewan) |
| Trial ID | NCT03272698 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a high intensity ketamine with ECT rescue (HIKER) approach compared to traditional electroconvulsive therapy (ECT) with ketamine anesthesia for patients suffering from treatment-resistant depression (TRD). Participants will be randomly assigned to either the HIKER group, receiving high intensity ketamine treatment over eight consecutive days, or the ECT with ketamine anesthesia group, receiving eight ECT treatments over a few weeks. The study will assess patient outcomes in terms of remission speed, side effects, and overall patient preference. The goal is to determine if the HIKER approach can reduce suffering and the need for ECT while being better tolerated by patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with treatment-resistant depression who have not responded to at least two different antidepressant therapies.
Not a fit: Patients who are unable to provide informed consent or have serious physical conditions that contraindicate ECT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a faster and more effective treatment option for patients with treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results with ketamine in treating depression, but this specific HIKER approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saskatoon, Saskatchewan
- Royal University Hospital — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Jonathan Gamble, MD — University of Saskatchewan
- Study coordinator: Una Goncin
- Email: ung039@usask.ca
- Phone: 3066551183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.