FDA Clears NeuroStar(R) TMS Therapy for the Treatment of ...(al effective dose and duration. Forty-ei...),Health

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 observed:

-- 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

effect declined
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