Jonathan J Gamble1, Henry Bi2, Rudy Bowen3, Grahme Weisgerber2, Rohan Sanjanwala2, Renuka Prasad3, Lloyd Balbuena3. 1. Department of Anesthesia, Perioperative Medicine, and Pain Management, University of Saskatchewan, Royal University Hospital, 103 Hospital Dr, Saskatoon, SK, S7N 0W8, Canada. J_Gamble@yahoo.com. 2. Department of Anesthesia, Perioperative Medicine, and Pain Management, University of Saskatchewan, Royal University Hospital, 103 Hospital Dr, Saskatoon, SK, S7N 0W8, Canada. 3. Department of Psychiatry, University of Saskatchewan, Royal University Hospital, Saskatoon, SK, Canada.
Abstract
BACKGROUND:Major depressive disorder (MDD) is a common and debilitating condition that can be challenging to treat. Electroconvulsive therapy (ECT) is currently the therapeutic gold standard for treatment-resistant MDD. We tested our hypothesis that ketamine-based anesthesia for ECT results in superior improvement in treatment-resistant MDD outcomes compared with propofol-based anesthesia. METHODS:Patients with treatment-resistant MDD were enrolled in a randomized clinical trial with assignment to ketamine- or propofol-based anesthesia arms. Using a modified intention-to-treat analysis, we compared the median number of ECT treatments required to achieve a 50% reduction (primary outcome) and a score ≤ 10 (secondary outcome) on the Montgomery-Asberg depression rating scale (MADRS) between anesthesia groups. RESULTS: The study was terminated as significant results were found after the first planned interim analysis with 12 patients in each of the ketamine (intervention) and propofol (control) groups. All ketamine patients achieved at least a 50% MADRS reduction after a median of two ECT treatments whereas ten propofol patients (83%) achieved the same outcome after a median of four ECT treatments. All ketamine patients and seven propofol patients (58%) achieved MDD remission (MADRS ≤ 10). Log rank tests showed that both time-to-50% reduction and remission differed significantly between groups. Adverse events and recovery time were similar between groups. CONCLUSIONS: In this early-terminated small-sized study, ketamine-based anesthesia compared with propofol-based anesthesia provided response and remission after fewer ECT sessions. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01935115). Registered 4 September 2013.
RCT Entities:
BACKGROUND: Major depressive disorder (MDD) is a common and debilitating condition that can be challenging to treat. Electroconvulsive therapy (ECT) is currently the therapeutic gold standard for treatment-resistant MDD. We tested our hypothesis that ketamine-based anesthesia for ECT results in superior improvement in treatment-resistant MDD outcomes compared with propofol-based anesthesia. METHODS:Patients with treatment-resistant MDD were enrolled in a randomized clinical trial with assignment to ketamine- or propofol-based anesthesia arms. Using a modified intention-to-treat analysis, we compared the median number of ECT treatments required to achieve a 50% reduction (primary outcome) and a score ≤ 10 (secondary outcome) on the Montgomery-Asberg depression rating scale (MADRS) between anesthesia groups. RESULTS: The study was terminated as significant results were found after the first planned interim analysis with 12 patients in each of the ketamine (intervention) and propofol (control) groups. All ketaminepatients achieved at least a 50% MADRS reduction after a median of two ECT treatments whereas ten propofolpatients (83%) achieved the same outcome after a median of four ECT treatments. All ketaminepatients and seven propofolpatients (58%) achieved MDD remission (MADRS ≤ 10). Log rank tests showed that both time-to-50% reduction and remission differed significantly between groups. Adverse events and recovery time were similar between groups. CONCLUSIONS: In this early-terminated small-sized study, ketamine-based anesthesia compared with propofol-based anesthesia provided response and remission after fewer ECT sessions. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01935115). Registered 4 September 2013.
Authors: Zach Walsh; Ozden Merve Mollaahmetoglu; Joseph Rootman; Shannon Golsof; Johanna Keeler; Beth Marsh; David J Nutt; Celia J A Morgan Journal: BJPsych Open Date: 2021-12-23