NCT00262665

Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dennis Charney · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ORG 24448	flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
DRUG	Placebo	matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2005-12-07
• Last updated: 2012-12-11