Depression - Major Depressive DisorderNCT07185438

Feasibility, Safety, and Preliminary Clinical Efficacy of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study

A study testing Experimental target rTMS treatment and Conventional target rTMS treatment in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Depression - Major Depressive Disorder
What is being tested?: Experimental target rTMS treatment and Conventional target rTMS treatment
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteChina
Study dates: 15 Sep 2025to 30 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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)
Patients currently using anticonvulsants or high-dose benzodiazepines
A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments

Show all 11Show fewer

A history of alcohol or substance abuse or dependence
Women who are pregnant or breastfeeding
Current high suicide risk
Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
Contraindications to MRI

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinyu Zhou contact

15823996993

zhouxinyu@cqmu.edu.cn

China1 site, 1 recruiting

The First Affiliated Hospital of Chongqing Medical University
Chongqing
Xinyu Zhou, 15823996993, zhouxinyu@cqmu.edu.cn
Recruiting

Other trials in China

About this study

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.

Read the detailed description

This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) 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 rTMS treatment group, the conventional target rTMS treatment group, and the sham stimulation group. All three groups will receive 4 weeks of rTMS stimulation (10 Hz, 120% RMT) or sham stimulation intervention, using the Blackdolphin TMS Robot (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions (administered on weekdays) in total. The intervention frequency and procedure will remain consistent across all groups.

In the experimental target rTMS 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 rTMS treatment group, participants will receive MRI-guided stimulation at the left DLPFC location. Participants in the sham stimulation group will receive a placebo treatment, simulating the rTMS procedure without generating an effective magnetic field output.

Primary outcomes include feasibility and acceptability indicators, such as recruitment, retention, adherence, assessment completion, and tolerability, as well as preliminary clinical efficacy. Secondary outcomes include anxiety, suicidal ideation and behaviour, and global clinical improvement. Safety will be monitored throughout.

Conditions: Depression - Major Depressive Disorder
Being tested: Experimental target rTMS treatment, Conventional target rTMS treatment, Sham stimulation treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental target rTMS treatmentDevice
Participants 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 treatmentDevice
participants will receive MRI-guided stimulation at the left DLPFC location.
Sham stimulation treatmentDevice
Participants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.

Study groups in NCT07185438
Study group	Role	What they receive
Experimental target rTMS treatment group	Experimental	Participants 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. Repetitive transcranial magnetic stimulation (rTMS) (10 Hz, 120% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions over 4 weeks (treatment administered on weekdays). Receives: Device: Experimental target rTMS treatment
Conventional target rTMS treatment group	Experimental	Participants will receive MRI-guided stimulation at the left DLPFC location. Repetitive transcranial magnetic stimulation (rTMS) (10 Hz, 120% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions over 4 weeks (treatment administered on weekdays). Receives: Device: Conventional target rTMS treatment
Sham stimulation treatment group	Sham comparator	Participants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output. The intervention will use a dedicated sham stimulation coil, which is identical in appearance, operation, and stimulation protocol to the experimental group. This coil is designed to maintain the same auditory and tactile sensations as the active stimulation but is equipped with an electromagnetic shielding structure or an internal reverse coil arrangement to effectively prevent magnetic flux from penetrating the skull, ensuring no actual neuromodulatory effects. Receives: Device: Sham stimulation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years
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.
Measured: Throughout the entire course of treatment (up to 1 month)
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.
Measured: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Incidence of Adverse Events and Serious Adverse Events
Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention. An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention. An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant. The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period. The severity, outcome, and relationship to the intervention will also be documented.
Measured: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)

Secondary outcomes (9)

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.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
The Pittsburgh Sleep Quality Index, abbreviated as PSQI, is a self-report questionnaire used to assess sleep quality and sleep disturbances over the past month. The 19 self-rated items are used to generate seven component scores, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 to 3, and the global PSQI score ranges from 0 to 21. Higher scores indicate poorer sleep quality. Changes in the global PSQI score from baseline will be assessed at the end of treatment and at follow-up visits.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
The Clinical Global Impression-Severity scale, abbreviated as CGI-S, is a clinician-rated scale used to assess the overall severity of illness at the time of evaluation. It is rated on a 7-point scale, ranging from 1 = normal, not at all ill to 7 = among the most extremely ill patients. Higher scores indicate greater illness severity. Changes in CGI-S score from baseline will be assessed at the end of treatment and at follow-up visits.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
The Clinical Global Impression-Improvement scale, abbreviated as CGI-I, is a clinician-rated scale used to assess the overall change in a participant's clinical condition compared with baseline. It is rated on a 7-point scale, ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate greater clinical improvement. CGI-I scores will be assessed at the end of treatment and at follow-up visits.
Measured: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in RRS (Ruminative Responses Scale)
The Ruminative Responses Scale, abbreviated as RRS, is a self-report scale used to assess the tendency to engage in ruminative thinking in response to depressed mood. The full version consists of 22 items, and each item is rated on a 4-point scale, ranging from 1 to 4. The total score ranges from 22 to 88. Higher scores indicate greater levels of rumination. Changes in RRS total score from baseline will be assessed at the end of treatment and at follow-up visits.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in PedsQL 4.0 score from baseline
The Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, abbreviated as PedsQL 4.0, is a standardized questionnaire used to assess health-related quality of life in children and adolescents. It consists of 23 items covering four domains: physical functioning, emotional functioning, social functioning, and school functioning. Raw item scores are reverse-scored and linearly transformed to a 0 to 100 scale, with 0=100, 1=75, 2=50, 3=25, and 4=0. The total scale score is calculated as the mean of all answered items, with higher scores indicating better health-related quality of life. Changes in PedsQL 4.0 total score from baseline will be assessed at the end of treatment and at follow-up visits.
Measured: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202530 Dec 2027

First posted22 Sep 2025
Study start15 Sep 2025
Primary completion15 Sep 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
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
Model description: This study employs a parallel assignment design. Participants will be randomly assigned in a 1:1:1 ratio to the experimental target rTMS treatment group, the conventional target rTMS treatment group, or the sham stimulation group. All three groups will utilize the Blackdolphin TMS Robot device (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., receiving 20 sessions of rTMS stimulation (10 Hz, 120% RMT) or sham stimulation over 4 weeks (with treatment administered on weekdays), with consistent intervention frequency and procedures. Participants will remain in their assigned group for the entire study duration without any crossover.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07185438
Sponsor's protocol ID: 1stChongqingCQMU___ZXY
Status last verified: May 2026
First submitted: 15 Sep 2025
Last updated: 26 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449
Croarkin PE, Elmaadawi AZ, Aaronson ST, Schrodt GR Jr, Holbert RC, Verdoliva S, Heart KL, Demitrack MA, Strawn JR. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology. 2021 Jan;46(2):462-469. doi: 10.1038/s41386-020-00829-y. Epub 2020 Sep 12.
PubMed 32919400
Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.
PubMed 28216033
Sigrist C, Vockel J, MacMaster FP, Farzan F, Croarkin PE, Galletly C, Kaess M, Bender S, Koenig J. Transcranial magnetic stimulation in the treatment of adolescent depression: a systematic review and meta-analysis of aggregated and individual-patient data from uncontrolled studies. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1501-1525. doi: 10.1007/s00787-022-02021-7. Epub 2022 Jun 24.
PubMed 35751003
Berlim MT, Van den Eynde F, Daskalakis ZJ. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials. Depress Anxiety. 2013 Jul;30(7):614-23. doi: 10.1002/da.22060. Epub 2013 Jan 24.
PubMed 23349112
O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PubMed 17573044
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832
Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst Rev. 2021 May 24;5(5):CD013674. doi: 10.1002/14651858.CD013674.pub2.
PubMed 34029378
Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
PubMed 18314433
March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
PubMed 15315995
Chen H, Xu D, Wang W, Luo X, Jiang X, Wan N, Wei Y, Wang T, Zhang L, Li X, Zhou X. Feasibility, safety, and preliminary clinical efficacy of resting-state functional connectivity MRI-guided rTMS for adolescents with major depressive disorder: Protocol for a randomized, double-blind, three-arm, sham-controlled pilot trial. PLoS One. 2026 Aug 6;21(8):e0355676. doi: 10.1371/journal.pone.0355676. eCollection 2026.
PubMed 42561002

Interested in taking part?

Xinyu Zhou

15823996993

zhouxinyu@cqmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility, Safety, and Preliminary Clinical Efficacy of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
ClinicalTrials.gov ID: NCT07185438
Acronym / sponsor ID: 1stChongqingCQMU___ZXY
Conditions: Depression - Major Depressive Disorder
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 45 participants (estimated)
Lead sponsor: First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Study start: 15 Sep 2025 (actual)
Primary completion: 15 Sep 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 22 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: This study employs a parallel assignment design. Participants will be randomly assigned in a 1:1:1 ratio to the experimental target rTMS treatment group, the conventional target rTMS treatment group, or the sham stimulation group. All three groups will utilize the Blackdolphin TMS Robot device (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., receiving 20 sessions of rTMS stimulation (10 Hz, 120% RMT) or sham stimulation over 4 weeks (with treatment administered on weekdays), with consistent intervention frequency and procedures. Participants will remain in their assigned group for the entire study duration without any crossover.

Arm	Type	Receives
Experimental target rTMS treatment group	Experimental	Device: Experimental target rTMS treatmentParticipants 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. Repetitive transcranial magnetic stimulation (rTMS) (10 Hz, 120% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions over 4 weeks (treatment administered on weekdays).
Conventional target rTMS treatment group	Experimental	Device: Conventional target rTMS treatmentParticipants will receive MRI-guided stimulation at the left DLPFC location. Repetitive transcranial magnetic stimulation (rTMS) (10 Hz, 120% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions over 4 weeks (treatment administered on weekdays).
Sham stimulation treatment group	Sham comparator	Device: Sham stimulation treatmentParticipants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output. The intervention will use a dedicated sham stimulation coil, which is identical in appearance, operation, and stimulation protocol to the experimental group. This coil is designed to maintain the same auditory and tactile sensations as the active stimulation but is equipped with an electromagnetic shielding structure or an internal reverse coil arrangement to effectively prevent magnetic flux from penetrating the skull, ensuring no actual neuromodulatory effects.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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)
Patients currently using anticonvulsants or high-dose benzodiazepines

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental target rTMS treatmentParticipants 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.	Device	Experimental target rTMS treatment group
Conventional target rTMS treatmentparticipants will receive MRI-guided stimulation at the left DLPFC location.	Device	Conventional target rTMS treatment group
Sham stimulation treatmentParticipants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.	Device	Sham stimulation treatment group

Primary outcome

Recruitment Feasibility (Number of Participants Enrolled)
Time frame: 2 years
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)
Time frame: Throughout the entire course of treatment (up to 1 month)
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)
Time frame: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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.
Incidence of Adverse Events and Serious Adverse Events
Time frame: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention. An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention. An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant. The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period. The severity, outcome, and relationship to the intervention will also be documented.

9 secondary outcomes

Change in BDI-II (Beck Depression Inventory-II) scores from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in HAMA score from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Time frame: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in RRS (Ruminative Responses Scale)
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
Change in PedsQL 4.0 score from baseline
Time frame: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
Background: PubMed 32919400Croarkin PE, Elmaadawi AZ, Aaronson ST, Schrodt GR Jr, Holbert RC, Verdoliva S, Heart KL, Demitrack MA, Strawn JR. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology. 2021 Jan;46(2):462-469. doi: 10.1038/s41386-020-00829-y. Epub 2020 Sep 12.
Background: PubMed 28216033Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.
Background: PubMed 35751003Sigrist C, Vockel J, MacMaster FP, Farzan F, Croarkin PE, Galletly C, Kaess M, Bender S, Koenig J. Transcranial magnetic stimulation in the treatment of adolescent depression: a systematic review and meta-analysis of aggregated and individual-patient data from uncontrolled studies. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1501-1525. doi: 10.1007/s00787-022-02021-7. Epub 2022 Jun 24.
Background: PubMed 23349112Berlim MT, Van den Eynde F, Daskalakis ZJ. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials. Depress Anxiety. 2013 Jul;30(7):614-23. doi: 10.1002/da.22060. Epub 2013 Jan 24.
Background: PubMed 17573044O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
Background: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Background: PubMed 34029378Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst Rev. 2021 May 24;5(5):CD013674. doi: 10.1002/14651858.CD013674.pub2.
Background: PubMed 18314433Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
Background: PubMed 15315995March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
Derived from this study: PubMed 42561002Chen H, Xu D, Wang W, Luo X, Jiang X, Wan N, Wei Y, Wang T, Zhang L, Li X, Zhou X. Feasibility, safety, and preliminary clinical efficacy of resting-state functional connectivity MRI-guided rTMS for adolescents with major depressive disorder: Protocol for a randomized, double-blind, three-arm, sham-controlled pilot trial. PLoS One. 2026 Aug 6;21(8):e0355676. doi: 10.1371/journal.pone.0355676. eCollection 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xinyu Zhou contact

15823996993

zhouxinyu@cqmu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinyu Zhou (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Feasibility (Number of Participants Enrolled) (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185438, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.