Research Study for Major Depressive Disorder: Investigation of Glutamate Medications



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 70
Updated:4/21/2016
Start Date:December 2006
End Date:September 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

Inclusion Criteria:

1. Male or female patients, 21- 70 years of age

2. Subjects have a history of at least one previous episode of depression prior to the
current episode (recurrent major depressive disorder) or have chronic major
depressive disorder (at least two years' duration)

3. Subjects have not responded to an adequate trial of one antidepressant in the current
episode

Exclusion Criteria:

1. Female subjects who are either pregnant or nursing

2. Serious, unstable illnesses

3. Any previous use or treatment with ketamine, or riluzole

4. Past intolerance to lamotrigine, including drug rash
We found this trial at
1
site
Mount Sinai School of Medicine
New York, New York 10029
?
mi
from
New York, NY
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