Marlene Busko
Medscape Medical News 2008. © 2008 Medscape
February 8, 2008 — The US Food and Drug Administration (FDA) has issued an Investigational Device Exemption (IDE) allowing enrollment to begin for a study of a device for deep brain stimulation for major depressive disorder, according to a statement issued by St. Jude Medical Inc (St. Paul, Minnesota), which holds intellectual property rights for the device.
The Brodmann Area 25 Deep Brain Neuromodulation (BROADEN) study will evaluate the safety and effectiveness of deep brain stimulation in patients with depression for whom currently available treatments are not effective.
This 12-month clinical trial will evaluate the Libra deep brain stimulation system, which is designed to deliver mild electrical pulses to the Brodmann Area 25 region of the brain in the prefrontal cortex, which appears to be overactive when people are profoundly depressed.
The deep brain stimulation system consists of a neurostimulator that is surgically implanted near the collarbone and connected to implanted leads and extension wires in the brain. The system also has an external controller and programmer.
The first study of deep brain stimulation in depression was done at the University of Toronto, in Ontario, by Helen S. Mayberg, MD (now with Emory University, in Atlanta, Georgia) and Andres Lozano, MD, and was published in Neuron in 2005.
"Major depressive disorder is severely disabling," said Dr. Lozano in a statement. "Currently, there are no widely accepted treatment options for patients with this condition once multiple medications, psychotherapy, and electroconvulsive therapy have failed."
The press release notes that in the United States, more than 21 million adults suffer from a depressive disorder, according to the National Institute of Mental Health, and of these, only about 80% can be effectively treated with currently available therapies, according to the National Advisory Mental Health Council.
"We are hopeful that this trial will lead to the successful development of a sustainable therapy for those patients who have exhausted other treatment options," said Chris Chavez, president of St. Jude Medical’s Advanced Neuromodulation Systems division.
To be eligible for the study, participants must:
- Be currently diagnosed with major depressive disorder.
- Be aged 21 to 70 years old, with onset of the first depression episode before age 45 years.
- Have tried at least 4 treatments in their current depression episode, such as different medications, various combinations of medications, or electroconvulsive therapy.
- Have been depressed for at least 1 year.
Study information is available at www.BROADENstudy.com or toll-free at 866-787-4332.
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