Back to resultsRandomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ORG 24448
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Org 24448
Placebo
Arm Description
ampa receptor potentiator for the treatment of MDD
matching placebo pill
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change in neuropsychological function from baseline to 7 weeks
Effect on neuropsychological functioning measured by neuropsychological testing
Full Information
NCT ID
NCT00262665
First Posted
December 6, 2005
Last Updated
December 10, 2012
Sponsor
Dennis Charney
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00262665
Brief Title
Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Official Title
Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
protocol cancelled
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dennis Charney
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Org 24448
Arm Type
Experimental
Arm Description
ampa receptor potentiator for the treatment of MDD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo pill
Intervention Type
Drug
Intervention Name(s)
ORG 24448
Other Intervention Name(s)
AMPA receptor potentiator
Intervention Description
flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
Primary Outcome Measure Information:
Title
mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks
Description
Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.
Time Frame
at baseline and at 8 weeks
Secondary Outcome Measure Information:
Title
change in neuropsychological function from baseline to 7 weeks
Description
Effect on neuropsychological functioning measured by neuropsychological testing
Time Frame
at baseline and at 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis S Charney, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
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