St. Jude Medical just received an Investigational Device Exemption (IDE) from the FDA that will allow the company to proceed with an extensive clinical trial of deep brain stimulation for the treatment of depression in patients that have failed other available forms of therapy.
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Drs. Mayberg and Lozano conducted the first study of deep brain stimulation (DBS) for depression in Toronto, Canada, in 2003 and published their findings in Neuron in March 2005. As reported in this journal article, imaging studies led them to an area of the brain thought to be involved in depression called Brodmann Area 25. This area appears to become overactive when people are profoundly sad and depressed.
St. Jude Medical owns the intellectual property rights and has various patents pending for the use of neurostimulation at Brodmann Area 25. The Libra(R) Deep Brain Stimulation System, which is being evaluated in this study, is designed to deliver mild electrical pulses from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.
To be eligible for the study, participants must:
— Currently be diagnosed with major depressive disorder
— Be between 21 and 70 years old, with onset of first episode
before age 45
— Have tried at least four treatments in their current episode,
such as different medications, various combinations of
medications or electroconvulsive therapy
— Have been depressed for at least one year.