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

NCT ID: NCT00262665

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Org 24448

ampa receptor potentiator for the treatment of MDD

Group Type EXPERIMENTAL

ORG 24448

Intervention Type DRUG

flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Placebo

matching placebo pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Interventions

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ORG 24448

flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Intervention Type DRUG

Placebo

matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Intervention Type DRUG

Other Intervention Names

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AMPA receptor potentiator

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Dennis Charney

OTHER

Sponsor Role lead

Responsible Party

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Dennis Charney

Dean

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dennis S Charney, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Countries

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United States

Other Identifiers

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GCO # 05-0384

Identifier Type: -

Identifier Source: org_study_id