SAN DIEGO, May 21 /PRNewswire/ -- New research on patients with
moderate-to-severe depression, who had not received adequate benefit from
previous antidepressant therapy, demonstrated that NeuroStar TMS
(Transcranial Magnetic Stimulation) Therapy significantly improved quality
of life and functioning when compared to patients receiving sham (placebo)
treatment. The new data were presented today at the American Psychiatric
Association's (APA) annual meeting.
"Symptom control is only meaningful in so far as it improves patients'
ability to function and enjoy life, which is an essential part of the
recovery process," said H. Brent Solvason, MD, Ph.D., Assistant Professor
of Psychiatry at Stanford University. Dr. Solvason was a primary
investigator in the NeuroStar TMS Therapy(TM) studies and is the lead
author of this data report. "Ideally, the combination of both symptomatic
and functional improvement should be the goal of treatment."
At baseline, the study population (N = 301) had significant symptomatic
and functional impairment related to depression. After four weeks of
treatment, patients receiving NeuroStar TMS Therapy (N = 155) experienced
statistically significant improvements in the General Health (P = 0.049)
and Mental Health (P = 0.006) subscales, as well as Mental Component Score
(P = 0.019) of the SF-36, a widely used health outcomes measure. After six
weeks, significant improvements were also seen in the SF-36 Role-Emotional
(P = 0.044) subscale and the Quality of Life Enjoyment and Satisfaction
Questionnaire--Q-LES-Q (P = 0.035), a common measurement tool used to
assess quality of life in patients suffering from depression. The effect
sizes observed in functional status improvement were similar in magnitude
to the effect sizes observed in symptomatic benefit.
"These data demonstrate that NeuroStar TMS Therapy produced significant
improvements in depressive symptoms that were accompanied by concurrent
improvements in patient-reported functional status and quality of life,"
said Dr. Solvason.
Significant Improvement of Depression Symptoms in Open-label Trial
A second trial presented at APA evaluated the acute efficacy of
NeuroStar TMS Therapy in an open-label setting, which more closely
resembles real-world clinical practice. In the open-label study, NeuroStar
TMS Therapy was administered as monotherapy in 158 patients for a six-week
period. At the end of six weeks, there was a three-week taper phase, which
included co-administration of medication monotherapy. Patients treated with
NeuroStar TMS Therapy experienced a significant improvement in symptoms,
from baseline, as early as Week Two. NeuroStar TMS Therapy-treated patients
also achieved a 42 percent response rate and a 27 percent remission rate at
the end of six weeks, as measured by the 24-item Hamilton Depression Rating
Scale (HAMD-24). At the end of the taper phase, the response rate increased
to 46 percent and the remission rate increased to 37 percent. The response
rate is the percentage of patients who experienced at least a 50 percent
improvement in symptoms. The remission rate is the percentage of patients
who experienced a virtually complete resolution of symptoms.
"The clinical significance of the treatment benefit is demonstrated by
the substantial proportion of patients who achieved both response and the
more stringent outcome of remission," said Mark A. Demitrack, MD, Chief
Medical Officer for Neuronetics, a psychiatrist, and an author of the
study. "The clinical significance of these data can also be demonstrated by
comparison with the recently reported outcomes from the large, open-label
STAR*D treatment study. Remission rates with NeuroStar TMS Therapy observed
in this study met or exceeded those reported for STAR*D when patients were
stratified by level of prior treatment failure."
The NeuroStar TMS Therapy system is an investigational, non-invasive
medical device studied clinically for the treatment of depression.
NeuroStar TMS Therapy is administered as an outpatient procedure, does not
require anesthesia or sedation, and can be performed in a psychiatrist's
office. It works by delivering highly focused MRI-strength magnetic field
pulses that stimulate nerve cells in the brain that are linked to
Neuronetics, Inc. is seeking marketing clearance for NeuroStar TMS
Therapy in patients with major depression who have failed to receive
adequate benefit from previous treatment. If cleared by the FDA, it will be
the first and only treatment of its kind in the U.S. for the treatment of
Depression affects at least 14 million American adults each year.
Researchers estimate that by the year 2020, depression will be the second
leading cause of disability worldwide. The economic burden of depression in
2000 was estimated at $83.1 billion in the US. Women are almost twice as
likely as men to suffer from depression.
However, some experts feel that depression in men is under-reported.
Depression has no racial, ethnic, or socioeconomic boundaries. About
two-thirds of those who experience an episode of depression will have at
least one other episode in their lives. Despite major advances in treating
this debilitating illness, nearly 30 percent of patients with depression do
not benefit from or are intolerant of antidepressant therapy.
Neuronetics, Inc. is a privately held medical device company focused on
developing non-invasive therapies for psychiatric and neurological
disorders using MRI-strength magnetic field pulses. Based in Malvern, PA.,
Neuronetics is the leader in the development of TMS Therapy, a non-invasive
form of neuromodulation. For more information, visit www.neuronetics.com.
Caution: Investigational device. Limited by federal law to
NeuroStar(R) and NeuroStar TMS Therapy(TM) are trademarks of
SOURCE Neuronetics, Inc.