Randomized, Placebo-Controlled Trial of an AMPAkine in Major Depressive Disorder - Full Text View

Sponsors and Collaborators:	Mount Sinai School of Medicine National Institutes of Health (NIH)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00262665

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: ORG 24448	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized, Placebo-Controlled Trial of an AMPAkine in Major Depressive Disorder

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Reduction of depressive symptoms as measured by the several depression rating scales at 8 weeks

Secondary Outcome Measures:

Effect on neuropsychological functioning measured at 7 weeks

Enrollment:	0
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2009

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical Diagnosis of MDD
Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to  3 antidepressant medications in the current or a previous episode

Exclusion Criteria:

1. Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262665

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574

Sponsors and Collaborators

Mount Sinai School of Medicine

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Dennis S Charney, MD

Mount Sinai School of Medicine

More Information

Study ID Numbers:	GCO # 05-0384
Study First Received:	December 6, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00262665
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009