NeuroStar(R) TMS Therapy Improved Quality of Life in Patients with Major Depression in Clinical Trials Separate Research Shows Significant Improvement of Symptoms in Open-label

Trial



    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
 depression.
     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
 major depression.
     About Depression
     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.
     About Neuronetics
     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
 investigational use.
     NeuroStar(R) and NeuroStar TMS Therapy(TM) are trademarks of
 Neuronetics, Inc.
 
 

SOURCE Neuronetics, Inc.

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