Trial results evaluating NeuroStar® Transcranial Magnetic Stimulation (TMS) therapy in depressed adolescents were posted on ClinicalTrials.gov on 2025-06-12. The study found that active TMS treatment reduced Hamilton Depression Rating Scale-24 (HAMD24) scores by -11.1 points, a change comparable to the -10.6 point reduction observed with sham treatment.
Background
Major Depressive Disorder (MDD) in adolescents is a serious mental health condition that can significantly impact development and quality of life. While pharmacotherapy and psychotherapy are common treatment approaches, some adolescents may not respond adequately or may experience intolerable side effects. Transcranial Magnetic Stimulation (TMS) offers a non-invasive alternative, using magnetic fields to stimulate nerve cells in the brain, and has been explored as a treatment option for depression.
Trial design
This completed study, which did not specify a traditional phase (Phase NA), enrolled 112 participants diagnosed with Major Depressive Disorder. The trial aimed to evaluate the safety and efficacy of daily, active NeuroStar® TMS therapy compared to a sham treatment. The primary focus was on the change from baseline in the Hamilton Depression Rating Scale-24 (HAMD24) total score.
Key results
The study measured the change from baseline in the Hamilton Depression Rating Scale-24 (HAMD24) total score:
- For the Phase I TMS Active group, the least squares mean change from baseline was -11.1 (Standard Error 2.03) score on a scale.
- For the Phase I TMS Sham group, the least squares mean change from baseline was -10.6 (Standard Error 2.00) score on a scale.
What this means
The key results indicate that both active NeuroStar TMS and sham treatment led to a reduction in HAMD24 scores in depressed adolescents. The observed reduction with active TMS (-11.1 points) was very similar to the reduction seen with sham treatment (-10.6 points). This suggests that in this specific trial, the active intervention did not demonstrate a substantially greater effect on HAMD24 scores compared to the placebo effect or spontaneous remission observed in the sham group. Further research may be needed to understand the specific efficacy of NeuroStar TMS in this population or to identify subgroups that might benefit more from the active treatment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02586688, titled "Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents", were posted on 2025-06-12 on clinicaltrials.gov.