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

Major Depressive Disorder Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT00262665
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2005
• Completion date: March 2005