Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01882829
Status:
COMPLETED
Last Update Posted:
2018-06-11
First Post:
2013-06-14
Brief Title:
Nuedexta in Treatment-Resistant Major Depression
Sponsor:
James Murrough
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Targeting the NMDA Glutamate Receptor as Novel Antidepressant Strategy A Pilot Clinical Trial of Nuedexta in Treatment-Resistant Major Depression
Status:
COMPLETED
Status Verified Date:
2018-05
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:
There is an urgent need therefore to identify well-tolerated orally available compounds that target the NMDA receptor as a novel treatment approach for TRD The current project aims to test the safety tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan
Detailed Description:
Approximately one-third of patients with major depressive disorder do not achieve adequate symptom control despite a series of multiple treatment trials with currently available antidepressant medication for example a serotonin-selective reuptake inhibitor This group of patients - representing treatment-resistant depression TRD - accounts for an alarmingly high public health burden and signifies a critical area of need in pharmaceutical treatment development While current treatments are slow to act and only partially effective new basic and clinical research focusing on the glutamate system is yielding promising new avenues for novel drug discovery Ketamine - a glutamate N-methyl-d-aspartate NMDA receptor antagonist - has now been demonstrated in several studies to bring about a rapid and robust antidepressant effect even in patients suffering from TRD Ketamine is limited as a treatment for TRD by the need for intravenous administration and the potential for untoward medical or psychiatric adverse effects There is an urgent need therefore to identify well-tolerated orally available compounds that target the NMDA receptor as a novel treatment approach for TRD The current project aims to test the safety tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IF1463152 | None | None | None |