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

This study has been withdrawn prior to enrollment.

(protocol cancelled)

Sponsor:

Collaborator:

National Institutes of Health (NIH)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2005

Last Updated Date

December 10, 2012

Start Date ^ICMJE

March 2005

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Reduction of depressive symptoms as measured by the several depression rating scales at 8 weeks

Change History

Complete list of historical versions of study NCT00262665 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Effect on neuropsychological functioning measured at 7 weeks

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Org 24448
ampa receptor potentiator for the treatment of MDD

Intervention: Drug: ORG 24448
Placebo Comparator: Placebo
matching placebo pill

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00262665

Other Study ID Numbers ^ICMJE

GCO # 05-0384

Has Data Monitoring Committee

Yes

Responsible Party

Dennis Charney, Mount Sinai School of Medicine

Study Sponsor ^ICMJE

Dennis Charney

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Dennis S Charney, MD

Mount Sinai School of Medicine

Information Provided By

Mount Sinai School of Medicine

Verification Date

December 2012

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

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