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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00262665
Recruitment Status : Withdrawn (protocol cancelled)
First Posted : December 7, 2005
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ORG 24448 Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Study Start Date : March 2005
Primary Completion Date : March 2005
Study Completion Date : March 2005
Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks [ Time Frame: 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 :
  1. change in neuropsychological function from baseline to 7 weeks [ Time Frame: at baseline and at 7 weeks ]
    Effect on neuropsychological functioning measured by neuropsychological testing


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262665


Sponsors and Collaborators
Dennis Charney
National Institutes of Health (NIH)
Investigators
Principal Investigator: Dennis S Charney, MD Icahn School of Medicine at Mount Sinai
More Information

Responsible Party: Dennis Charney, Dean, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00262665     History of Changes
Other Study ID Numbers: GCO # 05-0384
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

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