Safety and Effectiveness of Accelerated Intermittent Theta Burst Stimulation for Reducing Self-Injury and Suicidal Behaviors in Adolescents with Major Depression

What this Trial Is About

Researchers are studying the use of accelerated intermittent theta burst stimulation aiTBS, a form of repetitive transcranial magnetic stimulation rTMS, in adolescents aged 12 to 18 years with major depressive disorder who have experienced non-suicidal self-injury NSSI or suicidal thoughts and behaviors. This trial aims to compare the effects of active aiTBS to a placebo sham treatment on reducing self-injury and suicidal behavior, assessing changes in clinical symptoms and brain function. The study is conducted with hospitalized patients and includes careful safety monitoring due to the sensitive nature of the conditions. Participants will be randomly assigned to receive either active or sham aiTBS treatments applied to the left dorsolateral prefrontal cortex. The active treatment consists of 1800 pulses delivered in 9-minute sessions, five times per day, with 60-minute intervals between sessions, for 10 consecutive days. The sham group will receive a placebo stimulation schedule matching the active treatment. Magnetic resonance imaging MRI scans will be performed before and after the treatment period to observe changes in brain structure and activity. Blood tests will monitor endocrine and metabolic changes related to NSSI, and pain sensitivity will be tracked daily. Throughout the study, participants will undergo assessments at baseline, immediately after the 10-day treatment, and at 4 and 8 weeks post-treatment. These evaluations include depression and anxiety rating scales, suicide and self-injury inventories, functional disability assessments, and monitoring for treatment side effects. The primary outcome is the change in self-harm behavior measured by the Deliberate Self-Harm Inventory. Safety will be closely observed using symptom scales and adverse event records, ensuring participant well-being during the trial lasting approximately 8 weeks post-treatment.

aiTBS for NSSI and Suicide in Adolescent Depression