Press Release: NeuroStar® Advanced Therapy Receives FDA Clearance for Adolescents With Depression
NeuroStar TMS Receives FDA Clearance for Adolescent Depression
March 25, 2024 — Malvern, Pennsylvania
Neuronetics, Inc. announced that the U.S. Food and Drug Administration cleared NeuroStar® Advanced Therapy as an adjunct treatment for Major Depressive Disorder (MDD) in adolescent patients ages 15–21.
The clearance expanded the population for whom NeuroStar TMS may be considered and provided an additional noninvasive treatment option for adolescents with MDD. NeuroStar TMS uses magnetic stimulation delivered through a coil positioned against the scalp to stimulate targeted regions of the brain involved in treatment.
Evidence Supporting the Adolescent Clearance
The FDA decision was supported in part by real-world clinical data collected through NeuroStar’s TrakStar® registry as well as published clinical evidence.
The FDA submission included a retrospective analysis of 1,169 adolescent and young-adult patients treated with NeuroStar. Neuronetics reported that 78% of patients included in the analysis achieved a clinically meaningful improvement in depression severity.
The FDA reviewed the real-world data together with available clinical literature when evaluating the expanded indication. The resulting clearance applies to NeuroStar Advanced Therapy when used as an adjunct treatment for MDD in patients ages 15–21.
It is important to distinguish the population represented in the supporting registry data from the FDA-cleared indication. The clinical data included patients across a broader adolescent and young-adult age range, while the cleared indication specifically applies to patients ages 15–21.
What This Means for Adolescents and Families
Depression during adolescence can affect school performance, relationships, sleep, motivation, daily functioning, and overall quality of life. Treatment decisions should therefore be based on an individualized psychiatric evaluation rather than on age or diagnosis alone.
NeuroStar TMS is a prescription treatment. Whether it is appropriate for a particular adolescent depends on factors such as diagnosis, current treatment, psychiatric and medical history, safety considerations, and the treating clinician’s assessment.
Families who want to understand eligibility, treatment sessions, safety considerations, and what to expect can learn more about NeuroStar TMS for adolescents.
NeuroStar TMS at Lotus Psychiatry & Wellness
Lotus Psychiatry & Wellness provides NeuroStar TMS evaluation and treatment planning as part of its psychiatric services. Patients interested in TMS begin with a clinical evaluation to determine whether the treatment may be appropriate for their individual needs.
For broader information about candidacy, screening, treatment sessions, and the NeuroStar treatment process, visit our NeuroStar TMS treatment page.
Patients specifically seeking local treatment information can also review TMS therapy in Boca Raton.
Book an Appointment or call (561) 563-6262 to contact Lotus Psychiatry & Wellness about evaluation and available treatment options.