aiTBS for NSSI and Suicide in Adolescent Depression

The study will evaluate the efficacy and safety of aiTBS in depressive patients with NSSI or suicidal thoughts and behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the left dorso-lateral prefrontal cortex. The treatment will apply active aiTBS rTMS involving 1800 pulses (9 minutes), 5x daily at 60 minutes intervals for 10 days. Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAM-D17), Hamilton Anxiety Scale (HAMA) and Young's Mania Scale (YMRS). Non-suicidal self injury will be assessed by the Deliberate Self-Harm Inventory (DSHI) and the Ottawa self-injury inventory (OSI). Suicidal ideation and behaviors assessments include Beck Suicidal Scale Inventory (BSI), the Columbia-Suicide Severity Rating Scale (C-SSRS), and several questions from Self-Injurious Thoughts and Behaviors Interview - Revised (SITBI-R). The World Health Organization Disability Assessment Schedule for children (WHODAS-Child) will be used to evaluate the overall function of adolescent patients. Treatment Emergent Symptom Scale (TESS) would be used to eliminate side effects of combined drugs at baseline and the adverse event record form (AERF) will be used to appraise the safety of aiTBS treatment using these parameters. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI). Fasting blood exams will be conducted to measuring the level of NSSI related endocrine and metabolic changes. To record the change in sensitivity to pain and examine the tolerability of the treatment for these participants, visual analogue scale (VAS) is employed after completing 5 sessions treatment every day.

• Changes in Hamilton Anxiety Scale (HAMA) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in Young's Mania Scale (YMRS) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in Beck Suicidal Scale Inventory (BSI) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in The Clinical Global Impression (CGI) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment]
• Changes in the The World Health Organization Disability Assessment Schedule for children (WHODAS2-child) [Срок оценки: Baseline, 4 week and 8 week post-treatment]
• Changes of high-resolution T1-weighted anatomical images [Срок оценки: Baseline, next day after 10 treatment days, and 8 week post-treatment]
• Changes of Diffusion Tensor Imaging [Срок оценки: Baseline, next day after 10 treatment days, and 8 week post-treatment]
• Changes of blood oxygenation level dependent (BOLD) functional imaging signals [Срок оценки: Baseline, next day after 10 treatment days, and 8 week post-treatment]