Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

July 16, 2019 updated by: Sanjay Johan Mathew, Baylor College of Medicine

Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
anticonvulsant medication
Other Names:
  • lamictal
subanesthetic dose of NMDAR antagonist
Other Names:
  • ketalar
glutamate release inhibitor
Other Names:
  • 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.
subanesthetic dose of NMDAR antagonist
Other Names:
  • ketalar
glutamate release inhibitor
Other Names:
  • rilutek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24, 48, or 72-hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sanjay Mathew, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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