Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

This study has been completed.

First Received: January 4, 2007 Last Updated: March 10, 2009 History of Changes

Sponsor:	Mount Sinai School of Medicine
Collaborator:	National Alliance for Research on Schizophrenia and Depression
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00419003

Purpose

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.

Condition	Intervention	Phase
Major Depression	Drug: Lamotrigine Drug: IV Ketamine Drug: Riluzole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Lamotrigine Riluzole Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

acute response to IV ketamine in patients with treatment resistant major depression (TRD)

Secondary Outcome Measures:

efficacy of Lamotrigine, a glutamate-release inhibiting medication FDA-approved for bipolar disorder, in decreasing IV ketamine psychotomimetic side effects

Enrollment:	26
Study Start Date:	December 2006
Estimated Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients, 21- 70 years of age
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)
Subjects have not responded to an adequate trial of one antidepressant in the current episode

Exclusion Criteria:

Female subjects who are either pregnant or nursing
Serious, unstable illnesses
Any previous use or treatment with ketamine, or riluzole
Past intolerance to lamotrigine, including drug rash

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419003

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Mount Sinai School of Medicine

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Sanjay Mathew, MD

Mount Sinai School of Medicine

More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. Epub 2009 Jul 9.

Study ID Numbers:	05-0850
Study First Received:	January 4, 2007
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00419003 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Anesthetics
Excitatory Amino Acid Agents
Depressive Disorder, Major
Neuroprotective Agents
Membrane Transport Modulators
Mental Disorders
Sensory System Agents
Therapeutic Uses
Ketamine
Analgesics
Excitatory Amino Acid Antagonists

Anesthetics, Intravenous
Riluzole
Depression
Central Nervous System Depressants
Cardiovascular Agents
Depressive Disorder
Protective Agents
Anesthetics, Dissociative
Pharmacologic Actions
Behavioral Symptoms
Anesthetics, General
Lamotrigine
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009