CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 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/NCT00768430
NCT00768430Phase 2Completed

Optimization of Intravenous Ketamine for Treatment-Resistant Depression: A Randomized, Placebo-Controlled, Triple-masked, Clinical Trial

Baylor College of Medicine·interventional·Posted Oct 8, 2008·Updated Jan 31, 2014

In Brief

A Phase 2 clinical trial evaluating Ketamine and Midazolam for Major Depressive Disorder (MDD) and Treatment Resistant Depression (TRD). Completed, enrolled 73 participants across 2 sites.

Detailed Summary

Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders. In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study. The study period can last up to 8 weeks, depending on your response to the study medication. There are two required overnight stays in our Research Commons as part of this study.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2008
Enrollment StartNov 1, 2008
Primary CompletionSep 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.7 years ago

Interventions

Ketaminedrug

Single dose .5 mg/kg IV (in the vein) infused over 40 minutes

Midazolamdrug

single dose 0.045 mg/kg IV infused over 40 minutes