Corcept initiates Phase III trial of psychotic drug

This trial is a randomized, double-blinded, placebo-controlled study which will enroll up to 450 patients at approximately 25 sites in the US. In connection with this study, Corcept also announced the signing of 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 patient will respond to treatment, this study will use a Corlux dose of 1200mg 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. The FDA has granted a fast-track designation for Corlux for the treatment of the psychotic features of psychotic depression. In addition, the FDA has indicated that Corlux will receive a priority review if no other treatment is approved for psychotic depression at the time Corcept submits its new drug application.

Joseph Belanoff, CEO of Corcept, said: “We are hopeful that the combination of an increased dose and the use of centralized ratings will allow us to definitively determine the efficacy of Corlux in the treatment of the psychotic features of psychotic depression.”