A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Sponsored by Corcept Therapeutics
About this trial
Last updated 13 years ago
Study ID
C-1073-06
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 75 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 18 years ago
What is this trial about?
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).
What are the participation requirements?
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).