A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

Psychosis Clinical Trial

Official title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Status Terminated

Clinical Trial Summary

Approximately 450 patients will be randomized to receive Mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of Mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.

Clinical Trial Description

Up to 450 patients with psychotic depression will be randomly assigned to receive either Mifepristone or matching placebo. Patients will be assessed by the Investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mental Disorders
• Psychosis
• Psychotic Depression
• Psychotic Disorders
• Severe Major Depression With Psychotic Features

• NCT number: NCT00637494
• Study type: Interventional
• Source: Corcept Therapeutics
• Status: Terminated
• Phase: Phase 3
• Start date: March 2008
• Completion date: June 2014