Comparing high intensity ketamine with ECT versus ECT with ketamine anesthesia for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.