An interventional study of 10 Hz Repetitive Transcranial Magnetic and Intermittent Theta Burst Stimulation in Depressive Disorder, Major Depressive Disorder and Adolescence, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 11 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
This trial compares two transcranial magnetic stimulation (TMS) protocols-10 Hz rTMS and intermittent theta burst stimulation (iTBS)-in adolescents with major depressive disorder. Eighty participants aged 11-19 years will be randomly assigned to receive either 10 Hz rTMS or iTBS over a two-week period. Clinical symptoms, cognitive function, brain imaging, and neurophysiological measures will be assessed at baseline, immediately post-treatment, and at a 1-month follow-up to evaluate both the immediate and sustained therapeutic effects and underlying mechanisms.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**Exclusion Criteria:**
Participants will receive 10 Hz rTMS applied to the left DLPFC at 100% resting motor threshold. Each session delivers 3,600 pulses (4-second trains, 26-second inter-train interval). Two sessions per day with a 4-hour interval, totaling 7,200 pulses daily, delivered over a 10-day treatment period.
Device: 10 Hz Repetitive Transcranial Magnetic
Participants will receive intermittent theta burst stimulation (iTBS) applied to the left DLPFC at 100% resting motor threshold. Each session delivers 1,800 pulses (triplet 50 Hz bursts at 5 Hz, 2-second on, 8-second off). Four sessions per day with a 1-hour interval, totaling 7,200 pulses daily, delivered over a 10-day treatment period.
Device: Intermittent Theta Burst Stimulation
Non-invasive brain stimulation using a figure-of-eight coil to deliver magnetic pulses to the left dorsolateral prefrontal cortex, with individualized neuronavigation-guided coil positioning.
Non-invasive brain stimulation using a figure-of-eight coil to deliver magnetic pulses to the left dorsolateral prefrontal cortex, with individualized neuronavigation-guided coil positioning.
Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score
Change in depressive symptom severity from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). The HAMD-24 is a clinician-administered scale with higher scores indicating greater depression severity.
Time frame: Baseline, Week 2, and Week 6
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Change in anxiety symptom severity from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Clinician-administered; higher scores indicate greater anxiety.
Time frame: Baseline, Week 2, and Week 6
Change in Beck Scale for Suicide Ideation (BSI-CV) Total Score
Change in suicidal ideation severity from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Higher scores indicate greater suicidal ideation severity.
Time frame: Baseline, Week 2, and Week 6
Change in Connor-Davidson Resilience Scale (CD-RISC-10) Total Score
Change in psychological resilience from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Higher scores indicate greater resilience.
Time frame: Baseline, Week 2, and Week 6
Change in Children's Depression Inventory (CDI) Total Score
Change in self-reported depressive symptoms from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Higher scores indicate greater depression severity.
Time frame: Baseline, Week 2
Change in Multidimensional Anxiety Scale for Children (MASC) Total Score
Change in self-reported anxiety symptoms from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Higher scores indicate greater anxiety.
Time frame: Baseline, Week 2
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Change in self-reported sleep quality from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Higher scores indicate poorer sleep quality.
Time frame: Baseline, Week 2
Change in N-back Task Reaction Time
Change in working memory performance (reaction time) across 1-back, 2-back, and 3-back conditions from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in N-back Task Accuracy
Change in working memory performance (accuracy) across 1-back, 2-back, and 3-back conditions from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Reaction Time
Change in executive function (reaction time) from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Number of Completed Categories
Change in executive function (completed categories) from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Number of Perseverative Errors
Change in executive function (perseverative errors) from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Accuracy
Change in executive function (accuracy) from baseline to Week 2 (end of treatment) .
Time frame: Baseline, Week 2
Change in Balloon Analog Risk Task (BART) Average Number of Pumps
Change in risk-taking behavior measured by average number of pumps per trial in the Balloon Analog Risk Task (BART), the primary index of risk-taking propensity, from baseline to Week 2 (end of treatment) . Higher average pumps indicate greater risk-taking tendency.
Time frame: Baseline, Week 2
Change in Cortical Thickness Measured by Structural MRI
Change in cortical thickness from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Cortical Surface Area Measured by Structural MRI
Change in cortical surface area from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Cortical Volume Measured by Structural MRI
Change in cortical volume from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Resting-State Functional Connectivity
Change in functional connectivity using ICA-based network analysis from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Reward-Related Brain Activation Measured by Task-Based fMRI
Change in neural response (BOLD signal) to reward (coins won) versus loss (coins lost) outcomes measured by the simple guessing task-based fMRI, from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Regional Cerebral Blood Flow Measured by Arterial Spin Labeling (ASL) MRI
Change in regional cerebral perfusion measured by arterial spin labeling (ASL) from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Resting-State EEG Relative Spectral Power in Theta, Alpha, and Beta Bands
Change in relative spectral power in theta (4-8 Hz), alpha (8-13 Hz), and beta (13-29 Hz) bands from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in TMS-Evoked Potential (TEP) Amplitude (N45, P60, N100, P180)
Change in amplitude of the N45, P60, N100, and P180 components of TMS-evoked potentials (TEP) following single-pulse TMS to left DLPFC, from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in TMS-Evoked Potential (TEP) Latency (N45, P60, N100, P180)
Change in latency of the N45, P60, N100, and P180 components of TMS-evoked potentials (TEP) following single-pulse TMS to left DLPFC, from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in TMS-Evoked Oscillations (TEO) Measured by Event-Related Spectral Perturbation
Change in TMS-evoked oscillations quantified using time-frequency analysis (event-related spectral perturbation) to assess alterations in cortical oscillatory dynamics from baseline to Week 2 (end of treatment).
Time frame: Baseline, Week 2
Change in Spatial N-Back Task Sensitivity Index (d')
Change in sensitivity index (d') in the 2-back condition of the Spatial N-Back Task, from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). The d' metric reflects spatial signal discriminability free from response bias.
Time frame: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Perseverative Errors
Change in the number of perseverative errors in the Wisconsin Card Sorting Test (WCST), from baseline to Week 2 (end of treatment) and to Week 6 (1-month follow-up). Perseverative errors are defined as incorrectly applying a previously correct sorting rule after a rule shift, directly indexing cognitive flexibility.
Time frame: Baseline, Week 2
Change in TMS-Evoked Cortical Source Strength (EEG Source Localization)
Change in TMS-evoked cortical source activity reconstructed in the source space, from baseline to Week 2 (end of treatment). Outcome measures include source current density and/or source amplitude within predefined cortical regions and post-stimulation time windows. Changes in source strength are used to assess treatment-related alterations in regional cortical activation.
Time frame: Baseline, Week 2
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Qilu Hospital of Shandong University →