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.
Drug: IV Ketamine
|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|
- 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
- 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
|Study Start Date:||December 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419003
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Sanjay Mathew, MD||Baylor College of Medicine|