Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00419003
First received: January 4, 2007
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Major Depression
Drug: Lamotrigine
Drug: IV Ketamine
Drug: Riluzole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • acute response to IV ketamine in patients with treatment resistant major depression (TRD) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    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:
  • efficacy of Lamotrigine, a glutamate-release inhibiting medication FDA-approved for bipolar disorder, in decreasing IV ketamine psychotomimetic side effects [ Time Frame: 24, 48, or 72-hrs ] [ Designated as safety issue: No ]
    Response differences based on lamotrigine and placebo pretreatment groups


Enrollment: 26
Study Start Date: December 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: IV Ketamine Drug: Riluzole
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: IV Ketamine Drug: Riluzole

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Baylor College of Medicine
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Sanjay Mathew, MD Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional 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
Study First Received: January 4, 2007
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 01, 2014