Bayesian adaptive randomization trial of intravenous ketamine for veterans with late-life, treatment-resistant depression.
Brittany O'Brien, Charles E. Green, Rayan K. Al Jurdi, Lee C. Chang, Marijn Lijffijt, Sidra Iqbal, Tabish Iqbal, Alan C. Swann, Sanjay J. Mathew
Contemporary Clinical Trials Communications December 1, 2019 DOI: 10.1016/j.conctc.2019.100432 (opens in new tab)
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Study at a glance
AI-extracted from the abstract| Characteristics | Adaptive randomization trial Peer reviewed |
|---|---|
| Population | Older depressed veterans with late-life treatment-resistant depression |
| Interventions | Ketamine Midazolam |
| Topics | Depression Ketamine Esketamine |
| Keywords | Adaptive design Bayesian trial design Late-life depression Veterans |
| Citations | 10 |
| Key findings | The study is ongoing; results are expected to inform the viability of ketamine treatment and optimal dosing strategies for patients with late-life treatment-resistant 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.
Comparable studies
Other randomized controlled trials on ketamine for depression, most cited first.
Citations in the library
Cited by 3
- Neural complexity EEG biomarkers of rapid and post-rapid ketamine effects in late-life treatment-resistant depression: a randomized control trial Neuropsychopharmacology April 19, 2023
- Therapeutic and Safety Outcomes of Intravenous Ketamine for Treatment-refractory Depression in a Veteran Population: A Case Series. Military Medicine December 20, 2022
- Identification of an Optimal Dose of Intravenous Ketamine for Late-Life Treatment-Resistant Depression: A Bayesian Adaptive Randomization Trial Neuropsychopharmacology November 27, 2021
Cites 12
- Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial American Journal of Psychiatry August 28, 2013
- Measurement of dissociative states with the Clinician‐Administered Dissociative States Scale (CADSS) Journal of Traumatic Stress 1998
- Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Archives of General Psychiatry December 1, 2000
- Double-Blind, Placebo-Controlled, Dose-Ranging Trial of Intravenous Ketamine as Adjunctive Therapy in Treatment-Resistant Depression (TRD) Molecular Psychiatry October 3, 2018
- Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial The International Journal of Neuropsychopharmacology March 17, 2009
and 7 more in the library