The results of the study, which are published in the Journal of Biological Psychiatry, showed that patients who received Corlux were more likely than patients who received placebo to achieve a rapid and sustained reduction in psychosis as measured by a 30% reduction in the BPRS (Brief Psychiatric Rating Scale) at day 7 sustained to day 28.
The study, known as Study 03, evaluated 600mg of Corlux administered once daily over a period of seven days in patients with psychotic major depression (PMD). Patients were not allowed to receive any antipsychotic or antidepressant medication for at least seven days prior to or during administration of the study drug. The study randomized 221 patients on a one- to-one basis to receive either Corlux or placebo.
The results of the study also indicated that Corlux was well tolerated. There were no statistically significant differences in adverse events observed between the Corlux group and the placebo group.
According to Dr Joseph Belanoff, CEO of Corcept, the company has based its three phase III clinical trials on the design of Study 03. Dr Belanoff went on to say that the company expects to report results from its phase III trials before the end of the year, and that these trials should support a new drug application to the FDA.