Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Phase 4CompletedNCT00419003

Baylor College of Medicine26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depression

Interventions

LamotrigineDRUG

anticonvulsant medication

KetamineDRUG

subanesthetic dose of NMDAR antagonist

RiluzoleDRUG

glutamate release inhibitor

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

Mount Sinai School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)

Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.

Time frame: 24 Hours

Data from ClinicalTrials.gov

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