FDA Approves TMS in Treatment of Adolescent Depression

FDA Approves TMS in Treatment of Adolescent Depression

This advancement has the potential to set a new treatment paradigm for how we address depression in our youth.

Kenneth Pages, MD

There’s been major news in Transcrancial Magnetic Stimulation (TMS) and we can’t wait to share it!

In a significant development for adolescent mental health, NeuroStar® Advanced Therapy has received FDA clearance for the treatment of major depressive disorder (MDD) in adolescents aged 15-21.

This pivotal milestone opens new avenues of hope and healing for young individuals experiencing depression.

Here are 5 things to know about the FDA’s clearance of TMS in the treatment of adolescent depression:

1. This approval is the first of its kind.

NeuroStar Advanced Therapy is the first and only TMS treatment to receive FDA clearance for adolescents with MDD. This groundbreaking approval marks a significant shift in the approach to adolescent mental health, offering a novel treatment option where traditional methods may fall short.

Learn more about NeuroStar here.

2. It’s backed by real-world data.

The FDA’s decision was informed by robust real-world data collected through NeuroStar’s proprietary TrakStar® platform. Analysis of data from over 1,000 adolescents demonstrated that 78% experienced clinically meaningful improvement in depression severity with NeuroStar TMS therapy. This compelling evidence underscores the therapy’s effectiveness in real-world settings, providing hope for adolescents and their families.

3. TMS is safe and effective.

NeuroStar TMS therapy has been deemed substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy for adolescent depression. The therapy’s safety profile, coupled with its notable efficacy in reducing depression symptoms, offers a promising treatment option for adolescents who have not found relief through traditional approaches alone.

4. Approval will speed access to treatment.

NeuroStar’s versatile coil design enables providers to address the treatment needs of adolescents with MDD immediately, without requiring additional hardware upgrades. This streamlined approach ensures timely access to TMS therapy, minimizing barriers to treatment and empowering adolescents on their journey towards mental wellness.

Learn more about TMS at Sonder here.

5. TMS is transforming adolescent health.

With an estimated 4.3 million U.S. adolescents affected by MDD, the FDA clearance of NeuroStar Advanced Therapy holds immense promise for the future of adolescent mental health care. By expanding the treatment options available for adolescent depression, NeuroStar TMS therapy is poised to transform lives, offering a practical and powerful solution for young individuals and their families.

Read more about our patients’ TMS results here.

The FDA’s clearance of NeuroStar TMS therapy for the treatment of adolescent depression represents a pivotal moment in mental health care. As awareness grows and accessibility improves, NeuroStar stands at the forefront of innovation– and our Sonder team will continue to stand alongside you, helping you navigate each step of your wellness care.


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