This Month in Psychopharmacology

FDA Allows Marketing of First Device to Treat ADHD

The US Food and Drug Administration (FDA) recently permitted marketing for the first medical device to treat attention deficit hyperactivity disorder (ADHD). The device, called the Monarch external Trigeminal Nerve Stimulation System (eTNS) is indicated by prescription only for children between the ages of 7 and 12 who are not currently taking prescription medication for ADHD. The Monarch eTNS system is a cell-phone sized device that generates a low-level electrical pulse and connects through a wire to a small patch placed on the patient’s forehead, just above the eyebrows that the child wears overnight. The system delivers low-level electrical current to the trigeminal nerve, which communicates with areas of the brain thought to be involved in ADHD. The FDA’s decision was based on results from a clinical trial (n=62) in patients with moderate to severe ADHD, in which the Monarch eTNS system significantly improved ADHD symptoms, compared to a placebo device. At the end of week four, the average ADHD Rating Scale (ADHD-RS) score in the active group decreased from 34.1 points at baseline to 23.4 points, compared to a decrease from 33.7 to 27.5 points in the placebo group. The novel device offers a safe, non-pharmaceutical therapeutic option for the treatment of ADHD in pediatric patients.

>> FDA Press Release


For more information on ADHD:


ADHD in Adults

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This Month in Psychopharmacology: ADHD