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

Phase 2

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: ORG 24448; Drug: Placebo

• Registration Number: NCT00262665
• Lead Sponsor: Dennis Charney

Brief 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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Org 24448	ORG 24448	ampa receptor potentiator for the treatment of MDD
Placebo	Placebo	matching placebo pill

Primary Outcome Measures

Name	Time	Method
mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks	at baseline and at 8 weeks	Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.

Secondary Outcome Measures

Name	Time	Method
change in neuropsychological function from baseline to 7 weeks	at baseline and at 7 weeks	Effect on neuropsychological functioning measured by neuropsychological testing