This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.
Age 12 - 18
Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode
Score≥40 on the CDRS-R
Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study.
Psychiatric comorbidities other than anxiety disorders
Depression with psychotic symptoms
Young Mania Rating Scale (YMRS) score >13
A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma)
Parallel
Experimental target rTMS treatment
DeviceParticipants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.
Conventional target rTMS treatment
Deviceparticipants will receive MRI-guided stimulation at the left DLPFC location.
Sham stimulation treatment
DeviceParticipants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.
Recruitment Feasibility (Number of Participants Enrolled)
The total number of participants successfully enrolled in this study will be recorded to assess recruitment feasibility. The goal is to recruit 45 participants (15 in each of the three groups) over a 2-year period.
Intervention adherence (number of participants who completed the full 20 treatment sessions)
This outcome measure will assess participants' adherence to the 20 sessions of transcranial magnetic stimulation. Adherence is defined as completing all 20 sessions. Adherence is calculated by dividing the number of participants who met this criterion by the total number of participants.
Retention Rate (Number of Participants Remaining at 6-Month Follow-up)
This outcome measure will assess the proportion of participants still enrolled in the study at the 6-month follow-up assessment. Retention rate is calculated as the number of participants who completed the 6-month assessment divided by the number of participants enrolled at baseline.
Response rate and remission rate of depressive symptoms
Preliminary clinical efficacy will be assessed by change in the Children's Depression Rating Scale-Revised (CDRS-R) total score from baseline. CDRS-R is a clinician-rated scale used to assess the severity of depressive symptoms in children and adolescents. It consists of 17 items, and the total score ranges from 17 to 113. Higher scores indicate more severe depressive symptoms. Changes in CDRS-R total score from baseline will be assessed at the end of treatment and at follow-up visits. Response rate of depressive symptoms will be defined as a ≥50% reduction in CDRS-R total score from baseline, and remission rate of depressive symptoms will be defined as a CDRS-R total score ≤28.
Change in BDI-II (Beck Depression Inventory-II) scores from baseline
The Beck Depression Inventory-II, abbreviated as BDI-II, is a 21-item self-report scale used to measure the severity of depressive symptoms. Each item is scored from 0 to 3, and the total score ranges from 0 to 63. Higher scores indicate more severe depressive symptoms. Changes in BDI-II total score from baseline will be assessed at the end of treatment and at follow-up visits.
Change in HAMA score from baseline
The Hamilton Anxiety Rating Scale, abbreviated as HAMA, is a clinician-rated scale used to assess the severity of anxiety symptoms. It consists of 14 items covering both psychic anxiety and somatic anxiety symptoms. Each item is scored from 0 to 4, and the total score ranges from 0 to 56. Higher scores indicate more severe anxiety symptoms. Changes in HAMA total score from baseline will be assessed at the end of treatment and at follow-up visits.
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
The Screen for Child Anxiety Related Emotional Disorders, abbreviated as SCARED, is a self-report scale used to assess anxiety symptoms in children and adolescents. The total score ranges from 0 to 82, with higher scores indicating more severe anxiety symptoms. The change in SCARED total score from baseline will be calculated at each post-baseline assessment time point.
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
The Columbia-Suicide Severity Rating Scale, abbreviated as C-SSRS, is a clinician-administered scale used to assess suicidal ideation and suicidal behavior. The C-SSRS Suicidal Ideation Severity Score ranges from 0 to 5, where 0 indicates no suicidal ideation and higher scores indicate more severe suicidal ideation. The change in C-SSRS Suicidal Ideation Severity Score from baseline will be calculated at each post-baseline assessment time point.
Click on the lead sponsor to view all of their trials.
