NCT06210100

aiTBS for NSSI and Suicide in Adolescent Depression

Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries with and without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) and suicidal attempts in patients with major depressive disorder.

Detailed description

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.

Conditions

• Non Suicidal Self Injury
• Suicidal Ideation
• Suicide and Self-harm

Interventions

Type	Name	Description
DEVICE	Active iTBS	Mag-TD stimulator
DEVICE	Sham iTBS	Mag-TD stimulator

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-12-31
• Completion: 2025-02-01
• First posted: 2024-01-18
• Last updated: 2024-08-16

Locations

2 sites across 1 country: China