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 Overview

• Status: Withdrawn
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ORG 24448; Drug: Placebo

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: AMPA receptor potentiator
PLACEBO_COMPARATOR: Placebo; matching placebo pill	Drug: Placebo; matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in neuropsychological function from baseline to 7 weeks	Effect on neuropsychological functioning measured by neuropsychological testing	at baseline and at 7 weeks

Collaborators and Investigators

• Sponsor: Dennis Charney
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (ACTUAL): March 1, 2005
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: December 6, 2005
• First Submitted That Met QC Criteria: December 6, 2005
• First Posted (ESTIMATE): December 7, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: GCO # 05-0384