NCT00226278

Safety Study of ORG 34517 for Major Depression With Psychotic Features

Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. The patient will be hospitalized for up to two weeks to monitor their medications and progress and will return to the site for periodic assessments.

Conditions

• Major Depressive Disorder
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	ORG 34517

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2005-09-26
• Last updated: 2008-03-31

Locations

1 site across 1 country: United States