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

NCT00262665 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-12-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ORG 24448

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Dennis Charney

    lead OTHER

Principal Investigators

  • Dennis S Charney, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-03-31
Completion
2005-03-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262665 on ClinicalTrials.gov