Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262665
Status:
WITHDRAWN
Last Update Posted:
2012-12-11
First Post:
2005-12-06
Brief Title:
Randomized Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Sponsor:
Dennis Charney
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Randomized Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Status:
WITHDRAWN
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
protocol cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test a candidate drug Org 24448in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder
Detailed Description:
Major depressive disorder MDD is a common severe chronic and often life-threatening illness Major depression contributes to significant morbidity and mortality Available pharmacotherapies for major depression are suboptimal in terms of speed of onset efficacy and tolerability Current medications for severe chronic mood disorders are not based on pathophysiological models of illness but rather are variation of monoaminergic-based therapies Org 24448 represents a new treatment approach for depression by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors This drug has been shown to have antidepressant features in preclinical models as well as cognitive-enhancing qualities
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