A Phase 3 interventional study of Mifepristone in Depressive Disorder, Major, sponsored by Corcept Therapeutics. Completed at 13 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-15.
Sponsored by Corcept Therapeutics · Phase 3, Interventional, and Treatment
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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 87 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Mifepristone
To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-07
To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Corcept Therapeutics