Corcept Therapeutics has completed patient enrollment in Corcept 09, the second of three Phase III clinical trials in which Corlux (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression (PMD).
The study is a randomized, double-blind, placebo-controlled study that is being conducted in Europe. The primary endpoint is the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28, a responder analysis. A secondary endpoint is the proportion of patients with at least a 50 percent improvement in the BPRS PSS at both Day 7 and Day 56. The BPRS is an 18-item rating instrument used to assess psychopathology, and the PSS includes the four items in the BPRS that specifically measure psychosis. Patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study.