Corcept Therapeutics has completed patient enrollment in Study 07, one of three Phase III clinical trials in which Corlux (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression (PMD).
Study 07 is a randomized, double-blind, placebo-controlled study. 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 56, a responder analysis. Specifically, 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 had at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study and will be hospitalized if clinically necessary. BPRS PSS assessments also will be made at Days 14, 28 and 42.