Comparing High Intensity Ketamine Treatment and Electroconvulsive Therapy with Ketamine Anesthesia for Treatment-Resistant Depression

What this Trial Is About

Major depressive disorder MDD is a common and disabling psychiatric illness affecting a significant portion of the population. This research aims to evaluate whether a high intensity ketamine treatment combined with electroconvulsive therapy ECT rescue, called the HIKER approach, can reduce suffering by speeding up remission, cause fewer side effects, reduce the need for ECT, and be preferred by most patients with treatment-resistant depression TRD. The study compares the HIKER method to standard ECT therapy with ketamine anesthesia EAST. Participants are randomly assigned to one of two groups. The HIKER group receives daily high intensity ketamine doses 0.50 mgkg for eight consecutive weekdays to induce unconsciousness similar to general anesthesia. The EAST group undergoes eight ECT sessions over 2-3 weeks with ketamine anesthesia combined with other medications to ensure safe anesthesia, using either unilateral or bilateral electrode placement. The ECT sessions are delivered by psychiatrists with seizure monitoring following usual medical standards. During the study, participants will be monitored for their response to treatment, including the number of treatments until disease remission, suicidal thoughts, cognitive function via MMSE tests, and satisfaction with treatment. Assessments occur from the start of treatment up to 8 weeks after, including follow-up 30 days after the last treatment. The study also tracks the need for rescue ECT in the ketamine-only group. Safety and side effects are carefully observed throughout the study period, which may last up to four weeks for remission evaluation and eight weeks for follow-up.

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