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www.fdanews.com/articles/62054-corcept-reports-negative-results-in-psychotic-depression-study

CORCEPT REPORTS NEGATIVE RESULTS IN PSYCHOTIC DEPRESSION STUDY

August 28, 2006

Corcept Therapeutics announced that the results of the first of its three Phase III trials evaluating Corlux for treating psychotic major depression were negative.

The study was a randomized, double-blind, placebo-controlled study. The primary endpoint, a responder analysis, was the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both day seven and day 56. The study revealed that 30.5 percent of the patients receiving Corlux and 28.6 percent of the patients receiving placebo responded to the treatment.

"There was an unusually high placebo response rate in this trial," Robert Roe, Corcept's president and head of development, said. "At day 56, for example, approximately 80 percent of the patients in both of the arms of the study were responders, as measured by a 50 percent improvement in BPRS PSS score."