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)

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.