MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
ARS measures effectiveness
of anti-depressant medications
By OMAR FORD
Medical Device Daily Staff Writer
It’s estimated in the U.S. that nearly 15 million people
experience a depressive disorder every year and that nearly
17% of adults in the U.S. will experience major depression
in their lifetime. And in that number research has shown
that many patients looking to treat their depression won’t
respond adequately to the first antidepressant treatment
they are prescribed.
So finding the right kind of treatment for major depressive
disorders is often challenging for patients and doctors
alike, but a new application by Aspect Medical (Norwood,
Massachusetts) might help eliminate some of the difficulties.
Results from the clinical study Biomarkers for Rapid
Identification of Treatment Effectiveness Trial in Major
Depression (BRITE), show that Aspect’s EEG-based
Antidepressant Treatment Response indicator, is a significant
predictor of patient response and remission after one
week of treatment with the commonly prescribed antidepressant
escitalopram. The company suggests that ATR has
the potential to positively impact depression treatment
outcomes by helping clinicians select the most effective
antidepressant for each patient early in their treatment.
The BRITE trial was conducted in collaboration with
investigators from nine facilities throughout the country
and saw 375 patients. Their response was defined by
researchers as a 50% improvement in depression symptoms
as measured by the Hamilton Depression Rating Scale
after seven weeks of treatment, and remission was defined
as recovery from depression after seven weeks of treatment.
In the study, ATR at one week predicted the response
and remission with 74% accuracy in subjects treated for
seven weeks with escitalopram, which was statistically significant.
These results were then published in the
September issue of the journal Psychiatry Research.
“The results of the trial have been reported in various
scientific sessions, but this is the first peer-review publication
of these results,” Amy Siegel VP of Strategic Marketing
for Aspect Medical told Medical Device Daily. “This is pretty
significant.”
ATR works by using six sensors to measure electrical
activity in the brain and translate it into a number between
0 and 100. Two of the sensors are placed on the ears and the
rest are placed along the head. The sensors hook up to a
laptop which measures the EEG. The test can be taken in an
office setting within 10 to 15 minutes.
Patients first get readings prior to taking medication,
then another about a week after the anti-depressant medicine
is administered.
The lower the score, derived from the ATR index the
least likely a patient is to respond to the treatment.
“You don’t know how someone is going to respond to
treatments,” Andrew Leuchter, MD a professor of Psychiatry
at the Semel Institute for Neuroscience and Human
Behavior at University of California Los Angeles,
principal investigator for the trial, and chair of Aspect’s
Neuroscience Advisory Board told MDD. “What ATR does is
lets us see within one week if patients are going to respond
to the therapy or not.”
Leuchter, who helped develop the device at UCLA back
in 2002 added that, while using ATR on patients doesn’t
predict the right dose of medication, it does give info on if
the right medication is being used to treat the illness.
“BRITE study results suggest that ATR could potentially
provide the greatest clinical benefit for those patients who
might be receiving a medication that is unlikely to help
them. Our results suggest that it may be possible to switch
these patients to a more effective treatment quickly. This
would help patients and their physicians avoid the frustration,
risk and expense of long and ineffective medication
trials,” said Leuchter. “Research has shown that depression
patients who do not get better with a first treatment
attempt experience prolonged suffering, are more likely to
abandon treatment altogether from lack of efficacy and
may become more resistant to treatment over time.”
In the future, the company plans to continue the ATR
research effort and conduct a multi-year follow-on study of
ATR called the PRISE-MD study (Personalized Response
Indicators of SSRI Effectiveness in Major Depression). This
study will is expected to prospectively evaluate the ability
of ATR to predict response to escitalopram as well as the
clinical utility of ATR-directed treatment with escitalopram
or an alternate treatment with bupropion. Funding for this
study comes from a grant from the National Institutes of
Health.
Phillip Devlin, VP of Emerging Tech at Aspect said that
the company is currently in talks with the FDA to decide
what regulatory path it would proceed down to obtain market
clearance of ARS, but stopped short of saying what that
clearance might be.
“This is very promising research,” Devlin touted.
Based on the findings, the company said it would be realistic
to expect to see the device commercialized in the
next five years.
(This story originally appeared in the Sept. 14, 2009,
edition of Medical Device Daily)
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