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

This study has been withdrawn prior to enrollment.
(protocol cancelled)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis Charney, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00262665
First received: December 6, 2005
Last updated: December 10, 2012
Last verified: December 2012
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:
  • mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks [ Time Frame: at baseline and at 8 weeks ] [ Designated as safety issue: No ]
    Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.


Secondary Outcome Measures:
  • change in neuropsychological function from baseline to 7 weeks [ Time Frame: at baseline and at 7 weeks ] [ Designated as safety issue: No ]
    Effect on neuropsychological functioning measured by neuropsychological testing


Enrollment: 0
Study Start Date: March 2005
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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:   21 Years to 55 Years
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:

  • Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Dennis Charney
Investigators
Principal Investigator: Dennis S Charney, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Dennis Charney, Dean, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00262665     History of Changes
Other Study ID Numbers: GCO # 05-0384
Study First Received: December 6, 2005
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014