NCT00212797

A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)

Prospective, Double-Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.

Detailed description

Major depression with psychotic features (psychotic depression) is the most debilitating disorder in the depressive disorders spectrum. It is associated with severe symptoms, prolonged course, poorer response rates, more residual symptoms, more frequent relapses and higher mortality, as compared to major depressive disorder. The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression. The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.

Conditions

• Depression
• Depressive Disorders
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Org 34517	low dose Org 34517
DRUG	Org 34517	high dose Org 34517
DRUG	Placebo	placebo

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-09-21
• Last updated: 2015-11-26