St. Jude Medical Inc. (NYSE:STJ) won U.S. Food & Drug Administration approval to expand its BROADEN study of deep-brain stimulation for major depressive disorders, allowing a maximum of 20 sites across the U.S. to enroll up to 125 patients.
The BROADEN study is investigating stimulation in the area of the brain called Brodmann Area 25 to determine whether it is a safe and effective treatment for severe depression. Prior to the expansion the study took place at three centers in Chicago, New York City and Dallas.
Deep-brain stimulation sends mild electrical pulses to the brain via an implanted device. Brodmann Area 25 is a region of the brain rich in serotonin transporters and is believed to influence changes in appetite and sleep, mood an anxiety, memory formation and self-esteem.
The study builds on previous St. Jude work that showed that 62 percent of patients experienced at least 40 percent reduction in symptoms of depression at six months of treatment. Of those patients, more than 90 percent maintained the improvement after a year.
“Deep brain stimulation could potentially change the way that we look at treating patients suffering with severe depression,” said Dr. Mark George, distinguished professor of psychiatry, radiology and neurology at the Medical University of South Carolina. “Treatments such as medications, psychotherapy and electroconvulsive therapy often fail to work for these very difficult-to-treat patients, so we are hopeful this research will provide us with a new approach to treating this debilitating condition.”
Boston Scientific Corp. (NYSE:BSX) is also deep into the neurostimulation and neuromodulation business, developing products for the treatment of hemorrhagic stroke, intracranial athero disease, and acute ischemic stroke. Medtronic Inc. (NYSE:MDT) launched its Activa device for the treatment of Parkinson’s disease earlier this year, after winning CE Mark approval in the European Union for it’s deep-brain stimulator for treatment of epilepsy last fall.
St. Paul, Minn.-based St. Jude won CE Mark approval for its Athena deep-brain stimulation programmer, designed to help physicians control the amount of current delivered to patients’ brains to treat Parkinson’s disease, in September 2010. The company landed Australian approval in January 2011.