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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This study has been withdrawn prior to enrollment.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

December 6, 2005
December 10, 2012
March 2005
March 2005   (final data collection date for primary outcome measure)
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.
Reduction of depressive symptoms as measured by the several depression rating scales at 8 weeks
Complete list of historical versions of study NCT00262665 on ClinicalTrials.gov Archive Site
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
Effect on neuropsychological functioning measured at 7 weeks
Not Provided
Not Provided
 
Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: ORG 24448
    flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
    Other Name: AMPA receptor potentiator
  • Drug: Placebo
    matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
  • Experimental: Org 24448
    ampa receptor potentiator for the treatment of MDD
    Intervention: Drug: ORG 24448
  • Placebo Comparator: Placebo
    matching placebo pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2005
March 2005   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00262665
GCO # 05-0384
Yes
Dennis Charney, Mount Sinai School of Medicine
Dennis Charney
National Institutes of Health (NIH)
Principal Investigator: Dennis S Charney, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP