drugset / Trial / NCT02556606

Ketamine for Treatment Resistant Late-Life Depression

NCT02556606

Phase 3 Completed 33 enrolled VA Office of Research and Development
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine the effectiveness of a single infusion of ketamine (KET), to determine which dose is optimal 7 days after infusion using Bayesian Adaptive Randomization, and to learn about how ketamine works in the body and brain in persons with late-life treatment resistant depression.

Timeline

Start
2015-10-01
Primary completion
2020-03-31
Completion
2020-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.1 mg/kg Intravenous
Subject Ketamine Small molecule 0.25 mg/kg Intravenous
Subject Ketamine Small molecule 0.5 mg/kg Intravenous
Comparator Midazolam Small molecule 0.03 mg/kg Intravenous