Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder

Study Description: This is a safety and pilot efficacy study of open, neuronavigated intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS) in medication-free youth with treatment-resistant major depression. The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents. Objectives: The study has two objectives: 1) To evaluate safety, feasibility, and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression; 2) To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression. Endpoints: Primary Endpoints: Children s Depression Rating Scale (CDRS); rates of treatment completion and adverse events on standard rating scales Secondary Endpoints: 1. Clinical Global Impression Improvement Scale (CGI-I) 2. Mood and Feelings Questionnaire (MFQ) 3. Screen for Child Anxiety Related Disorders (SCARED) 4. Resting state fMRI correlations across brain regions 5. Task-based fMRI activation to cognitive conflict 6. Fractional anisotropy on diffusion tensor imaging 7. Neurochemicals assessed by magnetic resonance spectroscopy