Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344682
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2006-06-22
Brief Title:
Memantine Augmentation of Antidepressants
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
A Randomized Double-Blind Pilot Study of Memantine Augmentation in Antidepressant Nonresponders or Incomplete Responders
Status:
COMPLETED
Status Verified Date:
2018-06
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 evaluating the efficacy and safety of the drug memantine trade name NAMENDA as an augmentation agent for the treatment of depression in people who are not fully responding to antidepressant medications
Detailed Description:
- Objective
The objective of this study is to evaluate the efficacy and safety of 20 mg of memantine administered once daily as an augmentation agent for subjects who have been taking antidepressants for at least 1 month but who have experienced an incomplete or absent therapeutic response
- Background
Memantine is a moderate affinity uncompetitive N-methyl-D-aspartate NMDA receptor antagonist that is approved for the treatment of moderate-to-severe dementia of the Alzheimers type It has been commercially available in 23 countries worldwide since 1982
There are reports in the published literature that suggest NMDA receptors may be involved in the etiology of depressive disorders The NMDA antagonist ketamine has been shown to have antidepressant effects in a placebo-controlled clinical trial Berman et al 2000 Uncompetitive NMDA receptor antagonists including memantine have been shown to exhibit antidepressant-like activity in animal models of depression Moryl et al 1993 Papp and Moryl 1994 Animal studies also support the possibility that uncompetitive NMDA receptor antagonists may work synergistically in combination with antidepressants in animal models of depression Rogoz et al 2001 Some authors have hypothesized a role for NMDA receptors in the therapeutic effects of numerous antidepressants Skolnick et al 1996
- Study Design and Duration
This is a randomized single site double-blind placebo-controlled parallel-group study in outpatients The study consists of an 8-week double-blind treatment period Approximately 25 patients will be randomized to each treatment group memantine or placebo for a total of approximately 50 patients
The objective of this study is to evaluate the efficacy and safety of 20 mg of memantine administered once daily as an augmentation agent for subjects who have been taking antidepressants for at least 1 month but who have experienced an incomplete or absent therapeutic response
- Background
Memantine is a moderate affinity uncompetitive N-methyl-D-aspartate NMDA receptor antagonist that is approved for the treatment of moderate-to-severe dementia of the Alzheimers type It has been commercially available in 23 countries worldwide since 1982
There are reports in the published literature that suggest NMDA receptors may be involved in the etiology of depressive disorders The NMDA antagonist ketamine has been shown to have antidepressant effects in a placebo-controlled clinical trial Berman et al 2000 Uncompetitive NMDA receptor antagonists including memantine have been shown to exhibit antidepressant-like activity in animal models of depression Moryl et al 1993 Papp and Moryl 1994 Animal studies also support the possibility that uncompetitive NMDA receptor antagonists may work synergistically in combination with antidepressants in animal models of depression Rogoz et al 2001 Some authors have hypothesized a role for NMDA receptors in the therapeutic effects of numerous antidepressants Skolnick et al 1996
- Study Design and Duration
This is a randomized single site double-blind placebo-controlled parallel-group study in outpatients The study consists of an 8-week double-blind treatment period Approximately 25 patients will be randomized to each treatment group memantine or placebo for a total of approximately 50 patients
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