Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder

This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) for the treatment of adolescent depression.

Adolescents diagnosed with Major Depressive Disorder (MDD) will be randomly assigned in a 1:1:1 ratio to one of three groups: the experimental target a-iTBS treatment group, the conventional target a-iTBS treatment group, and the sham stimulation group. All three groups will receive 10 consecutive days of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation intervention, using the Blackdolphin TMS Robot (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions in total. The intervention frequency and procedure will remain consistent across all groups.

In the experimental target a-iTBS treatment group, participants will undergo MRI-guided identification of the left dorsolateral prefrontal cortex (DLPFC) region, where the voxel most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) will serve as the stimulation target. In the conventional target a-iTBS treatment group, participants will have the standard F3 target in the DLPFC identified via MRI guidance as the stimulation site. Participants in the sham stimulation group will receive a placebo treatment, simulating the a-iTBS procedure without generating an effective magnetic field output.

The primary outcome of the treatment phase is the efficacy rate or the remission rate of depressive symptoms. Secondary outcomes include symptom scales, anxiety symptoms, suicide risk, quality of life, sleep, rumination, and cognition. Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.

• Change in BDI-II (Baker Depression Scale) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]
• Change in RSS (Ruminative Responses Scale) [Срок оценки: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months]