In the indicated patient population, the following efficacy results
were observed in the randomized, controlled study:
-- The primary efficacy measure, the Montgomery-Asberg Depression Rating
Scale (MADRS) symptom score change at 4 weeks, was statistically
significantly superior to placebo (p=0.0006), among NeuroStar-treated
patients. Similar results were observed with the Hamilton Depression
Rating Scale (HAMD).
-- NeuroStar TMS Therapy-treated patients had statistically significant
response and remission rates, which were approximately twice the rate of
placebo-treated patients. The response rate is the percentage of
patients who had a greater than or equal to 50% improvement in symptoms,
and the remission rate is the percentage of patients who achieved
virtually complete symptom resolution.
-- NeuroStar TMS Therapy also produced statistically significant
improvements on the HAMD factor scores for core depression symptoms,
anxiety symptoms, somatization, and psychomotor retardation.
Throughout the NeuroStar TMS Therapy studies, more than 10,000 active
TMS treatments were safely performed. The following were the safety results
-- No systemic side effects, such as weight gain, sexual dysfunction,
sedation, nausea, or dry mouth
-- No adverse effects on concentration or memory
-- No seizures
-- No device-drug interactions
-- The most common adverse event related to treatment was scalp pain or
discomfort at the treatment area during active treatments, which was
transient and mild to moderate in severity. The incidence of this side
|SOURCE Neuronetics, Inc.|
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