Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial. The main questions this trial aims to answer are: * Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents? * Is SAINT® a feasible option as a first-line treatment for adolescent depression? Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment. Adolescent participants will: * Remain antidepressant-free throughout the study period of 6-7 weeks. * Receive an MRI of their head for precision targeting * Receive 5 days of aiTBS (SAINT®)

NCT Number	NCT06523439
Lead Sponsor	University of Texas at Austin Collaborators: Magnus Medical
Conditions	Major Depressive Disorder, Depression in Adolescence, Depression, Major Depressive Episode
Enrollment	40 participants
Start Date	2025-01
Primary Completion	2026-09 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2024-12-12