NCT00419003

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.

Detailed description

This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, continuation-phase study.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	Lamotrigine	anticonvulsant medication
DRUG	Ketamine	subanesthetic dose of NMDAR antagonist
DRUG	Riluzole	glutamate release inhibitor

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2007-01-05
• Last updated: 2019-07-31
• Results posted: 2016-03-21

Locations

1 site across 1 country: United States