Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-27 @ 4:24 PM
Study NCT ID:
NCT00419003
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2007-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5M01RR000071-46 | NIH | None | https://reporter.nih.gov/quic… | View |