Journal
CONTEMPORARY CLINICAL TRIALS
Volume 77, Issue -, Pages 19-26Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2018.12.009
Keywords
Electroconvulsive therapy; Ketamine; Clinical trial; Non-inferiority; Major depression; Treatment-resistant
Funding
- Patient Centered Outcomes Research Institute (PCORI) Award [PCORI/TRD-1511-33648]
- Agency for Healthcare Research and Quality [K12HS023000]
- Brain and Behavior Research Foundation
- Robert E. Leet and Clara Guthrie Patterson Trust
- American Foundation for Suicide Prevention
- Yale Department of Psychiatry
- NCT [03113968]
- HSRP [20164159]
- Yale New Haven Health
- National Center for PTSD VA CT Healthcare System
- State of Connecticut Department of Mental Health and Addiction Services
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Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited availability, stigma, and concerns about cognitive side effects. Ketamine has emerged as the first rapid-acting antidepressant and shows robust short-term efficacy in clinical trials, but there are concerns about its long-term safety and efficacy. While response rates are similar between ECT and ketamine in clinical trials, these treatments have never been compared head-to-head in a sufficiently large, well-powered randomized study. Here we describe the study protocol for ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression (ELEKT-D), a non-inferiority, comparative effectiveness trial. Patients with TRD seeking clinical treatment are randomized (1:1) to receive ECT (thrice weekly) or intravenous ketamine (twice weekly) for 3-5 weeks. The primary outcome is the proportion of responders in each group at the end of study visit, as measured by a patient-reported outcome measure (Quick Inventory of Depressive Symptomatology-Self Report). The study is powered such that the non-inferiority margin allows for ketamine to retain 90% of the ECT treatment effect, with a projected sample size of 400 patients (200 per group). Secondary outcomes include remission rates, depression severity, cognitive functioning, quality of life, adverse events, and tolerability. The results of the ELEKT-D study will have important implications for patient choice, clinical practice, and health insurance policies.
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