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CompletedPhase 4Results posted

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

NCT00419003 · Baylor College of Medicine

Closed to entry
Status
Not accepting participants
Phase 4
Phase
26
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)

    Measured over 24 Hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Mount Sinai School of MedicineNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT00419003 on ClinicalTrials.gov →

Last updated in the registry 2019-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits