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

Launched by UNIVERSITY OF SASKATCHEWAN · Sep 1, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring two different treatments for people suffering from treatment-resistant depression, which means they have not found relief from their depression despite trying at least two standard medications. The study compares a method called high intensity ketamine with ECT rescue (HIKER), where participants will receive high doses of ketamine for eight days, against a more traditional approach called ECT with ketamine anesthesia (EAST), where participants will undergo eight sessions of electroconvulsive therapy (ECT) over a few weeks. The goal is to see if the HIKER method can reduce symptoms more quickly, cause fewer side effects, require less ECT, and be preferred by patients.

To participate in this trial, individuals must be between 65 and 74 years old, have a certain level of depression as measured by a specific scale, and be scheduled to receive ECT therapy. They should also have tried two different medications without success. However, those with serious health issues, certain medical devices, or specific mental health conditions may not be eligible. Participants can expect to be randomly assigned to one of the two treatment groups and will be closely monitored throughout the study. This research is currently looking for volunteers to join.

Gender

ALL

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.