NCT00768430

Optimization of IV Ketamine for Treatment Resistant Depression

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder (MDD)
• Treatment Resistant Depression (TRD)

Interventions

Type	Name	Description
DRUG	Ketamine	Single dose .5 mg/kg IV (in the vein) infused over 40 minutes
DRUG	Midazolam	single dose 0.045 mg/kg IV infused over 40 minutes

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2008-10-08
• Last updated: 2014-01-31
• Results posted: 2014-01-31

Locations

2 sites across 1 country: United States