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Pediatric TMS Safety Registry Reports No Serious Events Across 1,200 Adolescents

A pediatric TMS safety registry reported no seizures or serious adverse events across 1,200 adolescents treated for depression at academic medical centers.

A multi-site pediatric TMS safety registry reported no seizures or other serious adverse events across 1,200 adolescents treated for depression at 14 academic medical centers between 2018 and 2024. The most common adverse events were transient scalp discomfort and mild headache, occurring in roughly a quarter of patients and resolving without intervention.

TMS is FDA-cleared only for patients 18 and older, but is used off-label at academic centers under research protocols for adolescents with treatment-resistant depression. The registry's safety findings are being cited by advocates seeking expanded labeling, including the FDA advisory committee that voted in favor of expanded labeling earlier this month.

Effectiveness data from the registry was consistent with adult outcomes: response in 53% and remission in 29% of patients across the cohort. Patients had typically failed at least one prior antidepressant trial before referral.

The American Academy of Child and Adolescent Psychiatry indicated it would update its treatment-resistant depression guidance once formal FDA action on adolescent labeling is final.

Source

Reporting based on coverage from Journal of the American Academy of Child & Adolescent Psychiatry. This article is editorial summary intended for general information; it is not medical advice.

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