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

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

Sponsors

Lead Sponsor: Dennis Charney

Collaborator: National Institutes of Health (NIH)

Source Icahn School of Medicine at Mount Sinai
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.

Overall Status Withdrawn
Start Date March 2005
Completion Date March 2005
Primary Completion Date March 2005
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks at baseline and at 8 weeks
Secondary Outcome
Measure Time Frame
change in neuropsychological function from baseline to 7 weeks at baseline and at 7 weeks
Condition
Intervention

Intervention Type: Drug

Intervention Name: ORG 24448

Description: flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Arm Group Label: Org 24448

Other Name: AMPA receptor potentiator

Intervention Type: Drug

Intervention Name: Placebo

Description: matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Arm Group Label: Placebo

Eligibility

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:

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dennis S Charney, MD Principal Investigator Icahn School of Medicine at Mount Sinai
Verification Date

December 2012

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Icahn School of Medicine at Mount Sinai

Investigator Full Name: Dennis Charney

Investigator Title: Dean

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Org 24448

Type: Experimental

Description: ampa receptor potentiator for the treatment of MDD

Label: Placebo

Type: Placebo Comparator

Description: matching placebo pill

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov