Corcept initiates fourth Ph II Corlux study

Corcept Therapeutics has announced the commencement of its fourth Phase III trial, Study 14, evaluating Corlux (mifepristone) for the treatment of the psychotic features of psychotic depression. This trial is a randomized, double-blinded, placebo-controlled study which will enroll up to 450 patients at around 25 sites in the USA. In connection with this, Corcept also signed an agreement with MedAvante, a provider of centralized clinical rating services.

The Study 14 protocol incorporates learnings from the three most recently completed Phase III trials. Based on confirmation of a correlation between the amount of drug in a patient's blood and the likelihood that the subject will respond to treatment, this study will use a Corlux dose of 1,200mg once per day for seven days. The study's primary endpoint will be a comparison of the number of patients who meet response criteria at both days seven and 56, as has been used in Corcept's previous studies of psychotic depression. MedAvante's centralized rating services are expected to increase the accuracy, reliability and quality of the psychiatric assessments. A review of past studies has also led to refinement of clinical site selection, says Corcept.