Bellevue,
Washington
98004
Purpose:
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).
Criteria:
Inclusion Criteria:
Individuals eligible for enrollment into this study are male and female adult patients
who:
- Are 18 to 75 years of age
- Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24
or 296.34)
- Are able to provide written informed consent
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
- Have a major medical problem
- Have previously participated in a Corlux (C-1073, mifepristone) clinical trial
- Have a history of an allergic reaction to Corlux (C-1073, mifepristone)