Depressive Disorder, Major Depressive DisorderNCT07873060
Comparing 10 Hz rTMS and iTBS for Adolescent Depression
A study testing 10 Hz Repetitive Transcranial Magnetic and Intermittent Theta Burst Stimulation in people with Depressive Disorder, Major Depressive Disorder and Adolescence, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Depressive Disorder, Major Depressive Disorder, Adolescence
- What is being tested?
- 10 Hz Repetitive Transcranial Magnetic and Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 11 to 19 years
- Meeting the DSM-5 criteria for MDD
- Absence of current or past psychotic symptoms (e.g., auditory or visual hallucinations)
- No comorbid schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, or other severe psychiatric conditions
- No contraindications to MRI or TMS, including implanted cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, or other metallic implants
Who cannot join
- Alcohol or substance dependence
- Severe or unstable medical conditions, including neurological, endocrine, and rheumatic diseases, brain disorders, traumatic brain injury or surgery, and infectious diseases
- Recent receipt of rTMS or electroconvulsive therapy
- High suicide risk
- A history of epilepsy or unprovoked seizures
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Mental Health Center
Jinan, Shandong, 250014
Duanwei Wang, +86 187 0531 7798, wren925@163.com
Kangcheng Wang, PhD
About this study
Official title: A Randomized Controlled Trial Protocol Comparing 10 Hz rTMS and iTBS for Adolescent Depression: Clinical Efficacy, Neurocognitive and Neurobiological Mechanisms
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.
- Being tested
- 10 Hz Repetitive Transcranial Magnetic, Intermittent Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Hz Repetitive Transcranial MagneticDevice
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.
Intermittent Theta Burst StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 Hz rTMS | Active comparator | 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. Receives: Device: 10 Hz Repetitive Transcranial Magnetic |
| iTBS | Experimental | 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. Receives: Device: Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, and Week 6
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: Baseline, Week 2
Change in Wisconsin Card Sorting Test (WCST) Accuracy
Change in executive function (accuracy) from baseline to Week 2 (end of treatment) .
Measured: 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.
Measured: Baseline, Week 2
Change in Cortical Thickness Measured by Structural MRI
Change in cortical thickness from baseline to Week 2 (end of treatment).
Measured: 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).
Measured: Baseline, Week 2
Change in Cortical Volume Measured by Structural MRI
Change in cortical volume from baseline to Week 2 (end of treatment).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Mental Health Center, Hangzhou Normal University, Shandong Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873060
- Sponsor's protocol ID
- KYSJWLL2025-1-019
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu X, Peng Z, Cheng F, Li G, Wang B, Hu C, Zhu Z, Hu S, Luo X, Sun J, Wang S, Fu J, Zhang W, Zhou D. Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation for Adolescents With Major Depressive Disorder: A Randomized, Double-Blind, Sham-Controlled Study. Biol Psychiatry. 2026 Feb 1;99(3):218-226. doi: 10.1016/j.biopsych.2025.07.018. Epub 2025 Jul 28.
PubMed 40738417Han S, Li XX, Wei S, Zhao D, Ding J, Xu Y, Yu C, Chen Z, Zhou DS, Yuan TF. Orbitofrontal cortex-hippocampus potentiation mediates relief for depression: A randomized double-blind trial and TMS-EEG study. Cell Rep Med. 2023 Jun 20;4(6):101060. doi: 10.1016/j.xcrm.2023.101060. Epub 2023 May 31.
PubMed 37263267Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18.
PubMed 35582784Bulteau S, Laurin A, Pere M, Fayet G, Thomas-Ollivier V, Deschamps T, Auffray-Calvier E, Bukowski N, Vanelle JM, Sebille V, Sauvaget A. Intermittent theta burst stimulation (iTBS) versus 10 Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) to alleviate treatment-resistant unipolar depression: A randomized controlled trial (THETA-DEP). Brain Stimul. 2022 May-Jun;15(3):870-880. doi: 10.1016/j.brs.2022.05.011. Epub 2022 May 21.
PubMed 35609816Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344Srivastava AV, Nemeroff CB, O'Sullivan SJ. TMS in adolescent depression: A milestone FDA clearance. Mol Psychiatry. 2026 Jun;31(6):3254-3256. doi: 10.1038/s41380-026-03455-0. Epub 2026 Feb 10. No abstract available.
PubMed 41667837Li CT, Chang WC, Cheng CM, Su TP, Bai YM, Tu PC. Comparative effects of 10-Hz rTMS and iTBS on cortico-striatal connectivity in major depressive disorder: a sham-controlled study. Mol Psychiatry. 2025 Nov;30(11):5084-5092. doi: 10.1038/s41380-025-03091-0. Epub 2025 Jun 28.
PubMed 40581658