Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

This randomised, double-blind, placebo-controlled trial (n=26) aims to investigate the safety and efficacy of ketamine and riluzole in patients with treatment-resistant major depressive disorder. Additionally, the study will assess whether lamotrigine can mitigate ketamine-associated side effects.

Conducted by Baylor College of Medicine, the trial enrolled ketamine-responsive patients and randomly assigned them to either riluzole or placebo for a four-week continuation phase. The primary outcome was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) to evaluate depressive symptoms following ketamine infusion. Secondary outcomes included the effectiveness of lamotrigine in reducing ketamine’s psychotomimetic effects.

Topic Depression Treatment-Resistant Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Completed
Results Published No
Start date 12 January 2006
End date 09 January 2008
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 26
Sex All
Age 21- 70
Therapy No

Trial Details

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. 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.

Trial Number NCT00419003

Sponsors & Collaborators

Baylor College of Medicine
This company doesn't have a full profile yet, it is linked to a clinical trial.

National Alliance for Research on Schizophrenia and Depression
This company doesn't have a full profile yet, it is linked to a clinical trial.

National Center for Research Resources
This company doesn't have a full profile yet, it is linked to a clinical trial.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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