NCT00637494

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Psychotic Depression
• Severe Major Depression With Psychotic Features
• Psychosis

Interventions

Type	Name	Description
DRUG	mifepristone	1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
DRUG	placebo	Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Timeline

• Start date: 2008-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2008-03-18
• Last updated: 2017-06-05
• Results posted: 2017-02-16

Locations

42 sites across 1 country: United States