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Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

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ClinicalTrials.gov Identifier: NCT00419003
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Lamotrigine Drug: Ketamine Drug: Riluzole Phase 4

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 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  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression
Study Start Date : December 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lamotrigine Pre-Treatment
Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. 300 mg of lamotrigine 2 hrs prior to ketamine infusion. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.
Drug: Lamotrigine
anticonvulsant medication
Other Name: lamictal

Drug: Ketamine
subanesthetic dose of NMDAR antagonist
Other Name: ketalar

Drug: Riluzole
glutamate release inhibitor
Other Name: rilutek

Placebo Comparator: Placebo Pre-Treatment
2 hours prior to ketamine infusion each patient received three capsules of placebo identical in size, weight, appearance, and taste to the lamotrigine tablets. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.
Drug: Ketamine
subanesthetic dose of NMDAR antagonist
Other Name: ketalar

Drug: Riluzole
glutamate release inhibitor
Other Name: rilutek




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression) [ Time Frame: 24 Hours ]
    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.


Secondary Outcome Measures :
  1. Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects [ Time Frame: 24, 48, or 72-hrs ]
    Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419003


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Baylor College of Medicine
National Alliance for Research on Schizophrenia and Depression
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Sanjay Mathew, MD Baylor College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanjay Johan Mathew, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00419003     History of Changes
Other Study ID Numbers: 05-0850
5M01RR000071-46 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2007    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Lamotrigine
Riluzole
Anticonvulsants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Neuroprotective Agents
Protective Agents