Testing the Safety and Effectiveness of SAINT4 Accelerated Intermittent Theta Burst Stimulation for Treating First Episode Depression in Adolescents Aged 14 to 19

What this Trial Is About

Researchers are evaluating the Stanford Accelerated Intermittent Neuromodulation Therapy SAINT4 protocol, a new form of transcranial magnetic stimulation TMS called accelerated intermittent theta burst stimulation aiTBS, for treating adolescents aged 14-19 years experiencing their first episode of major depressive disorder MDD. This open-label clinical trial aims to see if SAINT4 can relieve depression symptoms and be a feasible first-line therapy for adolescents who have not undergone prior full depression treatment and remain antidepressant-free during the trial. Participants will receive one of two SAINT4 treatment regimens delivered via a MagPro X100 TMS device with a Cool-B65 AP coil. One group will receive 10 daily sessions 50 total over 5 days, while the other will receive 5 daily sessions 25 total over 5 days. Each session involves bursts of magnetic stimulation targeted to a specific brain area identified by MRI. Sessions last about 10 minutes with 50-minute breaks between them, delivered at 90% of resting motor threshold adjusted for scalp-to-cortex distance. During the study, adolescents will remain antidepressant-free for 6-7 weeks, undergo an MRI for precise treatment targeting, and attend all study visits. Researchers will assess depressive symptoms using rating scales at baseline and one month after treatment. Parents will also provide feedback on the acceptability of SAINT4 as a first treatment option. Safety and feasibility will be closely monitored throughout the trials duration, which runs until September 2026.

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents