Bayesian adaptive randomization trial of intravenous ketamine for veterans with late-life, treatment-resistant depression.
Brittany O'brien, Charles E Green, Rayan Al-jurdi, Lee Chang, Marijn Lijffijt, Sidra Iqbal, Tabish Iqbal, Alan C Swann, Sanjay J Mathew
Contemporary clinical trials communications December 1, 2019 Peer reviewed DOI: 10.1016/j.conctc.2019.100432 via PubMed
Summary
The study investigates the safety, tolerability, efficacy, and durability of three different low doses of intravenous ketamine compared to an active placebo in older veterans suffering from treatment-resistant late-life depression. It employs an adaptive randomization design that adjusts participant allocation based on treatment effectiveness. The findings aim to enhance understanding of ketamine as a treatment option for this demographic.
Study at a glance
| Design | adaptive randomization trial |
|---|---|
| Population | older depressed veterans with treatment-resistant late-life depression |
Abstract
More than eleven million U.S. Veterans are at least 65 years of age, an age group of which almost 20% suffers from clinically significant depressive symptoms. Available pharmacological treatments are suboptimal for patients, including veterans, with late-life depression. Ketamine has emerged as a potentially promising rapid-acting therapy for treatment-resistant depression (TRD). However, few studies have examined the safety, tolerability and efficacy of ketamine therapy for older adults with late-life TRD (LL-TRD). This study uses an adaptive randomization design to test the safety, tolerability, efficacy, and durability of three distinct, single sub-anesthetic doses of intravenous (IV) ketamine versus a single dose of active placebo (midazolam) in older depressed veterans. As the study progresses, Bayesian adaptive randomization recalibrates randomization ratios to allocate more participants to conditions demonstrating greater promise and fewer participants to conditions with less promise. Secondary analyses explore clinical and biological moderating and mediating factors of rapid treatment response. Results are expected to inform both the viability of ketamine treatment and optimal dosing strategies for patients with LL-TRD.