Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder|
- mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks [ Time Frame: at baseline and at 8 weeks ] [ Designated as safety issue: No ]Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.
- change in neuropsychological function from baseline to 7 weeks [ Time Frame: at baseline and at 7 weeks ] [ Designated as safety issue: No ]Effect on neuropsychological functioning measured by neuropsychological testing
|Study Start Date:||March 2005|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Experimental: Org 24448
ampa receptor potentiator for the treatment of MDD
Drug: ORG 24448
flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
Other Name: AMPA receptor potentiator
Placebo Comparator: Placebo
matching placebo pill
matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
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.
|Principal Investigator:||Dennis S Charney, MD||Mount Sinai School of Medicine|