NCT00128479

A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).

Conditions

• Major Depressive Disorder
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	mifepristone	mifepristone 300 mg daily for 7 dats
DRUG	mifepristone matched placebo	daily for 7 days
DRUG	mifepristone 600 mg	mifepristone 600 mg daily for 7 days
DRUG	mifepristone 1200 mg	mifepristone 1200 mg daily for 7 days

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-08-10
• Last updated: 2012-02-15

Locations

44 sites across 1 country: United States