CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.5mg/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/NCT02579928
NCT02579928Phase 4Completed
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Efficacy of Rapid-Acting NMDA Antagonist for Treatment of Adolescent Depression and Anxiety Disorders

Yale University·interventional·Posted Oct 20, 2015·Updated Jul 14, 2020

In Brief

A Phase 4 clinical trial evaluating Ketamine and Midazolam for Major Depressive Disorder and Anxiety Disorder. Completed, enrolled 17 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Anxiety Disorder
CountriesUnited States
CollaboratorsAmerican Academy of Child Adolescent Psychiatry.

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartOct 1, 2015
Primary CompletionSep 28, 2018
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.7 years ago

Interventions

Ketaminedrug

A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.

Midazolamdrug

A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.