Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419003
• Other study ID #: 05-0850
• Secondary ID: 5M01RR000071-46
• Status: Completed
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Lamotrigine
anticonvulsant medication
• Ketamine
subanesthetic dose of NMDAR antagonist
• Riluzole
glutamate release inhibitor

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Alliance for Research on Schizophrenia and Depression, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects	Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups	24, 48, or 72-hrs
Primary	Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)	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