Psychotic Depression

Corcept has completed three Phase 3 trials to evaluate the safety and efficacy of CORLUX for the treatment of the psychotic features of psychotic depression. The study design of an ongoing fourth  Phase 3 trial calls for the enrollment 450 patients in a double-blind placebo controlled trial. The trial was initiated in March 2008 and enrollment is ongoing.  We are conducting this trial at approximately eight clinical sites in order to focus our resources on the completion of our NDA for CORLUX in Cushing’s Syndrome, and thus do not expect data from our psychotic depression study to be available during 2010. The FDA granted ‘fast track’ status to this program in 2001, underscoring the significant unmet need in this therapeutic area.

While psychiatrists typically choose between two approaches: electroconvulsive therapy (ECT) and combination drug therapy (simultaneous use of antidepressant and antipsychotic medications), there is no FDA-approved treatment for psychotic depression. By modifying the level and release pattern of cortisol within the human body, Corcept believes that CORLUX will be able to treat the psychotic features of psychotic depression more quickly and effectively and with fewer side effects than is possible with currently available treatments.