Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Information source: Mount Sinai School of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Lamotrigine (Drug); IV Ketamine (Drug); Riluzole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mount Sinai School of Medicine Official(s) and/or principal investigator(s):
Sanjay Mathew, MD, Principal Investigator, Affiliation: Mount Sinai School of Medicine
Overall contact:
Mara Steinbugler, MA, Phone: 212-241-6383, Email: mara.steinbugler@mssm.edu
Summary
his 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.
Clinical Details
Official title: Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: acute response to IV ketamine in patients with treatment resistant major depression (TRD)
Secondary outcome: efficacy of Lamotrigine, a glutamate-release inhibiting medication FDA-approved for bipolar disorder, in decreasing IV ketamine psychotomimetic side effects
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 IV
racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a
4-week, randomized, double-blind, continuation-phase study.
Eligibility
Minimum age: 21 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mara Steinbugler, MA, Phone: 212-241-6383, Email: mara.steinbugler@mssm.edu
Mount Sinai School of Medicine, New York, New York 10029, United States; Recruiting
Mara Steinbugler, MA, Phone: 212-241-6383, Email: mara.steinbugler@mssm.edu
Sanjay Mathew, MD, Principal Investigator
Additional Information
Starting date: December 2006
Ending date: July 2008
Last updated: January 16, 2007
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