CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Ketamine +3 moredrug
Likely dose
Ketamine 0.1mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02556606
NCT02556606Phase 3Completed
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Ketamine for Treatment Resistant Late-Life Depression

VA Office of Research and Development·interventional·Posted Sep 22, 2015·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating Ketamine and Midazolam for Treatment Resistant Depressive Disorder. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 22, 2015
Enrollment StartOct 1, 2015
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.8 years ago

Interventions

Ketaminedrug

randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg

Ketaminedrug

randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg

Ketaminedrug

randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg

Midazolamdrug

single 40 min infusion of MID 0.03mg/Kg