Study 09 is a randomized, double-blind, placebo-controlled study being conducted in Europe. The primary endpoint is the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both day seven and day 28. A secondary endpoint is the proportion of patients with at least a 50% improvement in the BPRS PSS at both day seven and day 56.
Patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study. Study enrollees may be either inpatients or outpatients.
Patients will receive either Corlux (mifepristone) or placebo, with those in the treatment group receiving 600mg of Corlux once daily for a period of seven days. All patients will receive antidepressant therapy starting on day one and through day 56.
Corcept expects to report results from the trial in September. Results from the first phase III study, Corcept 07, are expected in August, and results from Corcept 06, the third phase III trial, are expected in Q4 2006.