CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 25mg/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/NCT02106325
NCT02106325Phase 2Completed

A Randomized, Double-Blinded Controlled Trial of an N-Methyl D-Aspartate Antagonist as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients

NYU Langone Health·interventional·Posted Apr 8, 2014·Updated Sep 14, 2018

In Brief

A Phase 2 clinical trial evaluating Ketamine and Diphenhydramine for Depression. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment for people with Major Depressive Disorder. This study plans to explore the potential that Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to the Emergency Department with severe depression. Since this is a controlled trial we will use an IV of Ketamine or and equivalent volume of Diphenhydramine. Subjects will be randomly assigned to receive Ketamine or Benadryl. Investigators will then compare measures of mood pre- and post-infusion in the Emergency Department. To supplement self-reported measures of depressive symptoms(e.g. mood), investigators will obtain objective measures of the biological aspects of Major Depressive Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.2 years ago

Interventions

Ketaminedrug

IV of Ketamine (.25mg/kg)

Diphenhydraminedrug

Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department