CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Ketamine +2 moredrug
Likely dose
Ketamine 0.5 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/NCT01558063
NCT01558063Phase 2Completed

The Antidepressant Action of Ketamine: Brain Chemistry

Columbia University·interventional·Posted Mar 20, 2012·Updated Dec 10, 2019

In Brief

A Phase 2 clinical trial evaluating Ketamine, Saline, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Depressed patients will be offered experimental treatment with a new, potentially fast-acting antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0 (placebo), 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg. If a patient does not respond to ketamine after the first infusion, it may be because s/he received ketamine placebo or the dose of ketamine was too low. In that case, an optional second scan and infusion of active ketamine (0.5 mg/kg) will be offered. This second scan will occur no later than weeks after the first scan/infusion (as scheduling permits). There is no guarantee that the patient will respond to the second ketamine infusion. Patients enrolled in the study are eligible for up to 6 months treatment with their study psychiatrist after the ketamine infusion(s). Healthy Volunteers: Healthy controls will receive an infusion of ketamine at a single dose (0.5 mg/kg). Volunteers will only receive one MRI scan and infusion.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.3 years ago

Interventions

Ketaminedrug

Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Salinedrug

Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI)procedure

90-minute scan during the 40-minute infusion.