CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Ketamine +4 moredrug
Likely dose
Ketamine 0.1 mg/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/NCT01920555
NCT01920555Phase 2Completed
CompareCT.gov

Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

Massachusetts General Hospital·interventional·Posted Aug 12, 2013·Updated Jun 19, 2018

In Brief

A Phase 2 clinical trial evaluating Ketamine and Placebo Midazolam for Treatment Resistant Depression. Completed, enrolled 99 participants across 6 sites.

Detailed Summary

This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Baylor College of Medicine, Icahn School of Medicine at Mount Sinai, Stanford University, University of Texas, Yale University

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 12, 2013
Enrollment StartDec 1, 2014
Primary CompletionJan 1, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.9 years ago

Interventions

Ketaminedrug

Dose of Ketamine will be 0.1 mg/kg - one single infusion

Ketaminedrug

Dose of Ketamine will be 0.2 mg/kg - one single infusion

Ketaminedrug

Dose of Ketamine will be 0.5 mg/kg - one single infusion

Ketaminedrug

Dose of Ketamine will be 1.0 mg/kg - one single infusion

Placebo Midazolamdrug

Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion