Clinical Data Completes Enrollment in Depression Trial

Clinical Data announced that its PGxHealth Division has completed enrollment in a pivotal Phase III study of Vilazodone, in development for the treatment of depression.

This randomized, double-blind, placebo-controlled trial was launched in the first quarter of 2006 and has now begun dosing of 410 patients with major depressive disorder enrolled at 10 investigative sites. This is one of two pivotal trials required for a new drug application, which the company hopes to file with the FDA in 2009.

In conjunction with this study, Clinical Data is analyzing genetic biomarkers that may correlate with the prediction of response to Vilazodone. The company anticipates announcing top-line efficacy and genetic biomarker results in the third quarter of 2007.

"The treatment of depression is currently hampered by overall poor response to first-line treatment options," Carol Reed, chief medical officer, said. "As demonstrated in the STAR*D study, response rates of less than 50 percent are the norm."

"Vilazodone has a novel mechanism of action based on its dual serotonergic properties as [a selective serotonin reuptake inhibitor] and 5HT1A partial agonist. This molecule would be the first of its kind in the market," she continued. "With the addition of genetic markers that predict higher response rates in targeted populations, Vilazodone may prove to be an even more effective therapy for depressed patients."