Skip to main content
OpenTrials
Completed

NCT Number: NCT00419003

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine

Drug

anticonvulsant medication

Other names: lamictal

ketamine

Drug

subanesthetic dose of NMDAR antagonist

Other names: ketalar

Riluzole

Drug

glutamate release inhibitor

Other names: rilutek

Primary outcomes

  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.

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression
  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2007
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.