Depression Clinical Trial
Official title:
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).
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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