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Sponsors and Collaborators: |
University of Massachusetts Forest Laboratories |
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Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00344682 |
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.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder |
Drug: Memantine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Pilot Study of Memantine Augmentation in Antidepressant Nonresponders or Incomplete Responders |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | February 2008 |
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).
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have been on 1 of the following medications for 4 or more weeks at or above the listed dose with no psychiatric medication dose changes for the past 25 days:
Exclusion Criteria:
Contact: Chelsea Wogsland, B.A. | 508-856-5312 | chelsea.wogsland@umassmed.edu |
Contact: Center for Psychopharmacologic Research and Treatment | 508-856-5928 |
United States, Massachusetts | |
Center for Psychopharmacologic Research and Treatment (University of Massachusetts Medical School) | Recruiting |
Worcester, Massachusetts, United States, 01605 |
Principal Investigator: | Eric G. Smith, M.D., M.P.H. | University of Massachusetts Medical School |
Study ID Numbers: | NAM-MD-34 |
Study First Received: | June 22, 2006 |
Last Updated: | June 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00344682 History of Changes |
Health Authority: | United States: Food and Drug Administration |
memantine Namenda augmentation add-on depression major depressive disorder |
MDD unipolar depression NMDA ketamine uncompetitive NMDA receptor antagonist |
Excitatory Amino Acids Neurotransmitter Agents Depression Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Dopamine Mental Disorders Mood Disorders Ketamine Memantine Dopamine Agents Antidepressive Agents |
Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Excitatory Amino Acid Agents Depressive Disorder Pharmacologic Actions |
Behavioral Symptoms Mental Disorders Therapeutic Uses Mood Disorders Memantine Dopamine Agents Central Nervous System Agents Antidepressive Agents Excitatory Amino Acid Antagonists |