ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol

Dec 21, 2018Contemporary clinical trials

Comparing Electroconvulsive Therapy and Ketamine in Patients with Hard-to-Treat Depression

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Abstract

A projected sample size of 400 patients will be randomized to compare ECT and ketamine for treatment-resistant depression.

Electroconvulsive therapy (ECT) is considered the gold-standard treatment for treatment-resistant depression (TRD).
Ketamine is noted for its rapid antidepressant effects but raises concerns regarding long-term safety and efficacy.
This study aims to compare the efficacy of ECT and ketamine in treating TRD through a non-inferiority trial design.
The primary outcome will measure response rates using a patient-reported depression symptom inventory.
Secondary outcomes will assess remission rates, cognitive function, quality of life, adverse events, and tolerability.

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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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ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol

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