Table 1.
Inclusion and exclusion criteria.
Fig 1.
Schedule of enrollment, interventions, and assessments.
Legend. Abbreviations: aTBS, accelerated theta burst stimulation; ATHF, Antidepressant Treatment History Form; NIH, National Institutes of Health; t, timepoint; TASS, Transcranial Magnetic Stimulation Safety Screen; TMS-EEG, transcranial magnetic stimulation and electroencephalography; TMS-EMG, transcranial magnetic stimulation and electromyography; X, occurs at that time. a If symptoms of mania occur.
Fig 2.
Legend. aTBS, accelerated theta burst stimulation; CDRS-R, Children’s Depression Rating Scale Revised; C-SSRS, Columbia–Suicide Severity Rating Scale; LICI, long-interval intracortical inhibition; MINI, Mini-International Neuropsychiatric Interview; N45, TMS-EEG evoked potential at 45 milliseconds; N100, TMS-EEG evoked potential at 100 milliseconds; TBS, theta burst stimulation; TMS-EEG, transcranial magnetic stimulation and electroencephalography; TMS-EMG, transcranial magnetic stimulation and electromyography. Additional screening assessments (Table 2) include the Transcranial Magnetic Stimulation Safety Screen [69], Antidepressant Treatment History Form [70], Pubertal Development Scale [71], Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) for participants aged 12 to 17 years [72] or the Mini-International Neuropsychiatric Interview for participants aged 18 years [73], Young Mania Rating Scale [74], Children’s Depression Rating Scale Revised (CDRS-R) [75], C-SSRS [68], Beck Depression Interview-II [76], and Clinical Global Impressions–Severity Scale [77]. Also discussed and noted at the screening visit are concurrent use of medications, adverse events (AEs), serious AEs (SAEs), the case report form (CRF), and concurrent psychotherapy. The screening visit can occur on the same day or across 2 consecutive days depending on participant preference.
Table 2.
Description of assessments.