NeuroStar Announces New Publication in JAACAP Open Highlighting Treatment Efficacy in Depressed Adolescents
Neuronetics (NASDAQ: STIM) announced significant findings published in JAACAP Open regarding the effectiveness of NeuroStar TMS therapy in treating adolescent and young adult depression. The study, based on the world's largest TMS outcomes dataset, analyzed 1,283 patients aged 12-21 and found that approximately 70% of patients showed clinically meaningful improvement.
Since receiving FDA clearance in March 2024 for treating adolescents aged 15-21, NeuroStar has seen a one-third increase in adolescent treatments. The research demonstrated similar efficacy to adult populations, with less than 1% reporting worsening symptoms. The study is particularly significant as only two FDA-approved medications exist for adolescent depression, both carrying major safety warnings.
Neuronetics (NASDAQ: STIM) ha annunciato importanti risultati pubblicati su JAACAP Open riguardo all'efficacia della terapia NeuroStar TMS nel trattamento della depressione in adolescenti e giovani adulti. Lo studio, basato sul più grande database mondiale di risultati TMS, ha analizzato 1.283 pazienti di età compresa tra 12 e 21 anni e ha rilevato che circa il 70% dei pazienti ha mostrato un miglioramento clinicamente significativo.
Da quando ha ottenuto l'autorizzazione FDA nel marzo 2024 per il trattamento di adolescenti tra i 15 e i 21 anni, NeuroStar ha registrato un aumento di un terzo nei trattamenti per adolescenti. La ricerca ha dimostrato un'efficacia simile a quella riscontrata negli adulti, con meno dell'1% dei pazienti che ha riportato un peggioramento dei sintomi. Lo studio è particolarmente rilevante poiché esistono solo due farmaci approvati dalla FDA per la depressione adolescenziale, entrambi con importanti avvertenze sulla sicurezza.
Neuronetics (NASDAQ: STIM) anunció hallazgos significativos publicados en JAACAP Open sobre la efectividad de la terapia NeuroStar TMS en el tratamiento de la depresión en adolescentes y adultos jóvenes. El estudio, basado en el conjunto de datos de resultados TMS más grande del mundo, analizó a 1,283 pacientes de entre 12 y 21 años y encontró que aproximadamente el 70% de los pacientes mostró una mejoría clínicamente significativa.
Desde que recibió la aprobación de la FDA en marzo de 2024 para tratar a adolescentes de 15 a 21 años, NeuroStar ha experimentado un aumento de un tercio en los tratamientos para adolescentes. La investigación demostró una eficacia similar a la de la población adulta, con menos del 1% reportando empeoramiento de los síntomas. El estudio es especialmente relevante dado que solo existen dos medicamentos aprobados por la FDA para la depresión adolescente, ambos con importantes advertencias de seguridad.
Neuronetics (NASDAQ: STIM)는 청소년 및 젊은 성인의 우울증 치료에 있어 NeuroStar TMS 치료의 효과에 관한 중요한 연구 결과를 JAACAP Open에 발표했습니다. 세계 최대 규모의 TMS 결과 데이터셋을 기반으로 한 이 연구는 12세에서 21세 사이의 1,283명 환자를 분석했으며, 약 70%의 환자가 임상적으로 의미 있는 개선을 보였다고 밝혔습니다.
2024년 3월 FDA 승인 이후 15세에서 21세 사이 청소년 치료가 3분의 1 증가했으며, 연구 결과는 성인과 유사한 효능을 보였고 증상 악화 보고는 1% 미만이었습니다. 이 연구는 청소년 우울증 치료용 FDA 승인 약물이 두 가지뿐이며, 둘 다 주요 안전 경고를 포함하고 있어 특히 중요합니다.
Neuronetics (NASDAQ : STIM) a annoncé des résultats significatifs publiés dans JAACAP Open concernant l'efficacité de la thérapie NeuroStar TMS dans le traitement de la dépression chez les adolescents et jeunes adultes. L'étude, basée sur la plus grande base de données mondiale de résultats TMS, a analysé 1 283 patients âgés de 12 à 21 ans et a révélé qu'environ 70 % des patients présentaient une amélioration cliniquement significative.
Depuis l'autorisation de la FDA en mars 2024 pour le traitement des adolescents de 15 à 21 ans, NeuroStar a constaté une augmentation d'un tiers des traitements chez les adolescents. La recherche a démontré une efficacité similaire à celle des adultes, avec moins de 1 % des patients rapportant une aggravation des symptômes. Cette étude est particulièrement importante car il n'existe que deux médicaments approuvés par la FDA pour la dépression chez les adolescents, tous deux comportant des avertissements majeurs de sécurité.
Neuronetics (NASDAQ: STIM) gab bedeutende Ergebnisse bekannt, die in JAACAP Open veröffentlicht wurden, bezüglich der Wirksamkeit der NeuroStar TMS-Therapie bei der Behandlung von Depressionen bei Jugendlichen und jungen Erwachsenen. Die Studie, basierend auf dem weltweit größten TMS-Ergebnisdatensatz, analysierte 1.283 Patienten im Alter von 12 bis 21 Jahren und stellte fest, dass etwa 70 % der Patienten eine klinisch bedeutsame Verbesserung zeigten.
Seit der FDA-Zulassung im März 2024 für die Behandlung von Jugendlichen im Alter von 15 bis 21 Jahren verzeichnet NeuroStar einen Anstieg der Behandlungen bei Jugendlichen um ein Drittel. Die Forschung zeigte eine ähnliche Wirksamkeit wie bei Erwachsenen, wobei weniger als 1 % eine Verschlechterung der Symptome berichteten. Die Studie ist besonders bedeutend, da es nur zwei von der FDA zugelassene Medikamente für jugendliche Depressionen gibt, die beide erhebliche Sicherheitswarnungen tragen.
- 70% of adolescent and young adult patients showed clinically meaningful improvement
- One-third increase in adolescent treatments since FDA clearance in March 2024
- Less than 1% of patients reported worsening symptoms
- Results consistent with adult population efficacy
- Expanding treatment options in an underserved market with limited FDA-approved alternatives
- None.
Insights
Neuronetics' clinical data confirms NeuroStar TMS efficacy in adolescents, supporting market expansion following recent FDA clearance.
The publication of real-world data in JAACAP Open represents a significant clinical validation for Neuronetics' (NASDAQ: STIM) NeuroStar TMS system in treating adolescent depression. The study leveraged the company's proprietary TrakStar database—the largest depression outcomes database globally—analyzing 1,283 adolescent and young adult patients.
The findings demonstrate approximately
From a market perspective, the company has already witnessed a
The adolescent market represents a strategic growth opportunity for Neuronetics, especially considering the limited pharmaceutical options (only two FDA-approved medications) for this demographic, both carrying significant safety warnings. NeuroStar's non-pharmaceutical approach positions it favorably as physicians and parents seek safer alternatives for this vulnerable population.
This publication strengthens Neuronetics' clinical foundation as they engage with providers and payers to expand reimbursement coverage, which will be crucial for broader market adoption in this newly approved indication. The company's proprietary TrakStar database continues to provide valuable real-world evidence that supports both clinical acceptance and payer discussions.
Real-world data showing NeuroStar is effective in adolescents and young adults with depression from the world’s largest TMS outcomes dataset
MALVERN, Pa., July 30, 2025 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the publication of significant real-world findings in the Journal of the American Academy of Child & Adolescent Psychiatry Open (JAACAP Open), a leading peer-reviewed medical journal covering pediatric psychiatry. The study found strong antidepressant treatment effects in adolescent and young adult patients treated with NeuroStar TMS (transcranial magnetic stimulation). The results in these adolescent and young adult patients were consistent with those previously reported in adults.1
“Since NeuroStar was the first TMS manufacturer to receive FDA clearance as an add-on therapy to treat adolescents, ages 15-21, with major depressive disorder in March 2024, we have seen over a one-third increase in adolescents being treated with NeuroStar, highlighting the importance and rapid uptake in the younger patient population,2” said Keith J. Sullivan, President and CEO of Neuronetics. “These findings reinforce the unique leadership role Neuronetics plays both as an innovator and a resource for clinical research with our proprietary TrakStar® dataset. We will continue to work with providers and payers to expand access to NeuroStar TMS for appropriate young patients.”
The findings are based on research from the NeuroStar TrakStar Clinical Database, the world's largest database of depression outcomes. In a sample of 1,283 patients comprised of 682 patients aged 12-19 and 601 patients aged 20-21, approximately
“These data, derived from the largest sample of adolescent and young adult patients who have received NeuroStar TMS, demonstrate the undeniable results NeuroStar TMS provides, which is consistent with the efficacy and meaningful benefit we see with adult populations,” said Todd M. Hutton, MD, Chief Medical Officer of Southern California TMS Center and former President of the Clinical TMS Society. “One in five adolescents experience an episode of major depressive disorder, and the majority go untreated as there are only two FDA-approved medications for this population and both come with major safety warnings.3,4,5 There is a huge opportunity for NeuroStar TMS to provide a safe and effective option to these patients at a critical time in their lives and development.”
For more information about NeuroStar TMS Therapy, please visit NeuroStar.com.
About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is delivering more treatment options to patients and physicians by offering exceptional in-office treatments that produce extraordinary results. NeuroStar Advanced Therapy is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, Neuronetics operates Greenbrook TMS Inc. (Greenbrook) treatment centers across the United States, offering NeuroStar Advanced Therapy for the treatment of MDD and other mental health disorders. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults, with more than 7.4 million treatments delivered, and is backed by the largest clinical data set of any TMS treatment system for depression, including the world’s largest depression outcomes registry. Greenbrook treatment centers also offer SPRAVATO® (esketamine) Nasal Spray, a prescription medicine indicated for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. It is also indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.1 Greenbrook has provided more than 1.8 million treatments to over 55,000 patients struggling with depression.
The NeuroStar Advanced Therapy System is cleared by the U.S. Food and Drug Administration for adults with MDD, as an adjunct for adults with obsessive-compulsive disorder, to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression), and as a first line adjunct for the treatment of MDD in adolescent patients aged 15-21. For safety information and indications for use, visit NeuroStar.com.
Neuronetics Contact:
Investors:
Mike Vallie or Mark Klausner
ICR Healthcare
443-213-0499
ir@neuronetics.com
Media:
EvolveMKD
646.517.4220
NeuroStar@evolvemkd.com
References:
- Croarkin PE, Aaronson ST, Carpenter LL, Hutton TM, Pages K, Chen B, Sackeim HA. The Effectiveness of Transcranial Magnetic Stimulation in Adolescents and Young Adults With Major Depressive Disorder. JAACAP Open (2025), doi: 10.1016/j.jaacop.2025.06.006.
- FDA 510(k) Clearance K231926. Data on File. Neuronetics. 2025.
- National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/major-depression#part_2565.
- Wilson, S. Dumornay, N.M. Rising Rates of Adolescent Depression in the United States: Challenges and Opportunities in the 2020s. J Adolesc Health. Mar 2022; 70:354-355.
- Flores, M.W., Sharp, A., Carson, N.J. et al. Estimates of Major Depressive Disorder and Treatment Among Adolescents by Race and Ethnicity. JAMA Pediatrics. 2023; 177:1215-1223.
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1 The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. For more important safety information about SPRAVATO®, please visit spravatohcp.com.
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