Abstract：
: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.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Mathew SJ,Wilkinson ST,Altinay M,Asghar-Ali A,Chang LC,Collins KA,Dale RM,Hu B,Krishnan K,Kellner CH,Malone DA,Murrough JW,Ostroff RB,Sanacora G,Shao M,Anand Adoi
10.1016/j.cct.2018.12.009subject
Has Abstractpub_date
2019-02-01 00:00:00pages
19-26eissn
1551-7144issn
1559-2030pii
S1551-7144(18)30491-9journal_volume
77pub_type
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journal_title：Contemporary clinical trials
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