Randomized, Placebo-controlled Trial of an AMPAkine in Ma... | NCT00262665

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

NCT00262665

Sponsor

Dennis Charney

Status

Withdrawn

Last Update Posted

Dec 11, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Major Depressive Disorder

Interventions

ORG 24448
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol cancelled

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Dec 6, 2005

First Submission Date that Met QC Criteria

Dec 6, 2005

First Posted Date

Dec 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Org 24448	Experimental	ampa receptor potentiator for the treatment of MDD	Drug: ORG 24448
Placebo	Placebo Comparator	matching placebo pill	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORG 24448	Drug	flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.	Org 24448

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	at baseline and at 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
change in neuropsychological function from baseline to 7 weeks	Effect on neuropsychological functioning measured by neuropsychological testing	at baseline and at 7 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis S Charney, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C521407	1-(benzofurazan-5-ylcarbonyl)piperidine
C000712967	AMPA receptor potentiator HBT1

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided