St Jude Medical announces clinical study of deep brain stimulation for
16 February 2008
St Jude Medical, Inc. (NYSE:STJ) will begin enrollment
in a controlled, multi-site, blinded, clinical study of deep brain
stimulation for major depressive disorder, a severe form of depression.
The BROADEN (Brodmann area 25 deep brain neuromodulation) study will
evaluate the safety and effectiveness of deep brain stimulation in patients
with depression for whom currently-available treatments are not effective.
The study will build upon the pioneering depression work of a research team
from the University of Toronto, led by neurologist Helen Mayberg MD (now
with Emory University School of Medicine), and neurosurgeon Andres Lozano
"Major depressive disorder is severely disabling," said Dr Lozano.
"Currently, there are no widely-accepted treatment options for patients
with this condition once multiple medications, psychotherapy and
electroconvulsive therapy have failed."
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.
In the US, more than 21 million adults
suffer from some kind of depressive disorder, according to the National
Institute of Mental Health. Of these, only about 80% can be effectively
treated with currently available therapies, according to the National
Advisory Mental Health Council. Unfortunately, that means approximately 4
million adult Americans live with depression that does not respond to
medications, psychotherapy and, in certain cases, electroconvulsive therapy.
"St. Jude Medical is dedicated to researching and developing
neuromodulation therapies for people who live with conditions such as severe
depression," said Chris Chavez, president of St. Jude Medical's ANS
Division. "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."
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
- Have tried at least four treatments in their current episode, such
as different medications, various combinations of medications or
electroconvulsive therapy; and
- Have been depressed for at least one year.
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