Memantine Augmentation of Antidepressants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Double-Blind Pilot Study of Memantine Augmentation in Antidepressant Nonresponders or Incomplete Responders|
- MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Modified QIDS-SR [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- HAM-A [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- BAC-A [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Cortisol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Suicide Assessment Scale [ Time Frame: thorughout study and at 8 weeks ] [ Designated as safety issue: Yes ]
- SADS Delusional Scale [ Time Frame: Baseline, week 4 and week 8 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
memantine 5mg - 20mg PO daily
Other Name: Namenda
|Placebo Comparator: Placebo||
Drug: Placebo comparator
5mg - 20mg PO daily over 8 weeks
Other Name: placebo
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.
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 Alzheimer's 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.
|United States, Massachusetts|
|Center for Psychopharmacologic Research and Treatment (University of Massachusetts Medical School)|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Kristina M Deligiannidis, M.D.||University of Massachusetts, Worcester|