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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
257
daily for 7 days
daily for 7 days
CNRI-LA
Pico Rivera, California, United States
Behavioral Health 2000, LLC
Riverside, California, United States
Cnri, Llc
San Diego, California, United States
University of Florida Clinical Trials
Jacksonville, Florida, United States
Quantum Laboratories/Memory Disorder Center
Pompano Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
American Medical Research, Inc.
Oak Brook, Illinois, United States
Valle Vista Health System
Greenwood, Indiana, United States
Psychopharmacology Research
Farmington Hills, Michigan, United States
Robert Horne, MD
Las Vegas, Nevada, United States
...and 13 more locations
The change in a measure of psychosis
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
The change in a measure of depression
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
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