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news.Clinical Data has initiated patient enrollment in a pivotal phase III clinical research study of vilazodone, a novel dual serotonergic compound being studied for treatment of depression.
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The company said that it anticipates having initial results from this study available by mid-2007 and anticipates at least one long-term safety study and one additional pivotal study will be required prior to filing a new drug application.
The trial will enroll approximately 400 adult patients diagnosed with major depressive disorder at eight US centers. As part of the trial, Clinical Data will also seek to discover genetic markers for response to vilazodone.
“We believe this study will demonstrate that vilazodone is an effective compound for the treatment of depression and, in addition, will generate a genetic database that will be unique in the development of an anti-depressant,” said Clinical Data’s president and CEO, Dr Israel Stein.
“The biomarkers we expect to discover in patients treated with vilazodone will enable physicians to identify a population of patients most likely to respond to the drug leading to an individualized treatment for depression,” continued Dr Stein.