Depression - Major Depressive DisorderNCT07369713
Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder
A study testing Experimental target a-iTBS treatment and Conventional target a-iTBS treatment in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) intervention for adolescent depression through a pilot clinical trial. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Experimental target a-iTBS treatment and Conventional target a-iTBS 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
- 1 Aug 2026to 1 Aug 2028
- 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 (2) 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 (3) Score≥40 on the CDRS-R (4) 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.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Xinyu Zhou, 15823996993, zhouxinyu@cqmu.edu.cn
About this study
Official title: Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) 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 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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Experimental target a-iTBS treatment, Conventional target a-iTBS 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 a-iTBS 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 a-iTBS treatmentDevice
Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site.
Sham stimulation treatmentDevice
Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.
| Study group | Role | What they receive |
|---|---|---|
| Experimental target a-iTBS 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. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days. Receives: Device: Experimental target a-iTBS treatment |
| Conventional target a-iTBS treatment group | Experimental | Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days. Receives: Device: Conventional target a-iTBS treatment |
| Sham stimulation treatment group | Sham comparator | Participants will receive a sham stimulation treatment designed to simulate the a-iTBS 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.
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Response rate of depressive symptoms (defined as ≥50% reduction in CDRS-R score) or remission rate of depressive symptoms (defined as CDRS-R score ≤28).
The CDRS-R scale ranges from 0 to 54, with higher scores indicating worse depressive symptoms.
Measured: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Secondary outcomes (8)
Change in BDI-II (Baker Depression Scale) scores from baseline
Change in Beck Depression Inventory - Second Edition (BDI-II) scores from baseline.
The BDI-II scale ranges from 0 to 63, with higher scores indicating worse depressive symptoms.
Measured: 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
Improvement in anxiety (SCARED minus the scores). The SCARED scale ranges from 0 to 82, with higher scores indicating worse anxiety symptoms.
Measured: 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)
The severity of the suicide risk. The C-SSRS scale ranges from 0 to 5, with higher scores indicating worse suicide risk severity.
Measured: 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
Improvement in sleep status (PSQI minus the scores). The PSQI scale ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: 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
Improvement of children's quality of life (PedsQL 4.0 minus the scores). The PedsQL 4.0 scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: 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
Improvement in overall clinical impression severity (7-point scale, with 1 being normal and 7 being among the most severely impaired).
The CGI-S scale ranges from 1 to 7, with higher scores indicating worse clinical severity.
Measured: 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
Improvement of clinical general impression (7-point scale, with 1 denoting very much improved and 7 denoting very much worse, with higher scores indicating worse clinical improvement).
Measured: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Change in RSS (Ruminative Responses Scale)
The level of improvement in negative thinking. The RSS scale ranges from 0 to 4 for each item, with a total possible score of 0 to 36, with higher scores indicating worse ruminative thinking.
Measured: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 a-iTBS treatment group, the conventional target a-iTBS 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 50 sessions of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation over 10 consecutive days, 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369713
- Sponsor's protocol ID
- 1stChongqingCQMU___ZXYa-iTBS
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07369713
- Acronym / sponsor ID
- 1stChongqingCQMU___ZXYa-iTBS
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 27 Jan 2026 (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.
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) 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.
Detailed description
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.
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 a-iTBS treatment group, the conventional target a-iTBS 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 50 sessions of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation over 10 consecutive days, 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 a-iTBS treatment group | Experimental | Device: Experimental target a-iTBS 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. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days. |
| Conventional target a-iTBS treatment group | Experimental | Device: Conventional target a-iTBS treatmentParticipants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days. |
| Sham stimulation treatment group | Sham comparator | Device: Sham stimulation treatmentParticipants will receive a sham stimulation treatment designed to simulate the a-iTBS 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 (2 listed)
- Age 12 - 18 (2) 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 (3) Score≥40 on the CDRS-R (4) 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 a-iTBS 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 a-iTBS treatment group |
| Conventional target a-iTBS treatmentParticipants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. | Device | Conventional target a-iTBS treatment group |
| Sham stimulation treatmentParticipants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output. | Device | Sham stimulation treatment group |
Primary outcome
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Time frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Response rate of depressive symptoms (defined as ≥50% reduction in CDRS-R score) or remission rate of depressive symptoms (defined as CDRS-R score ≤28). The CDRS-R scale ranges from 0 to 54, with higher scores indicating worse depressive symptoms.
8 secondary outcomes
Change in BDI-II (Baker Depression Scale) scores from baseline
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Change in RSS (Ruminative Responses Scale)
Time frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 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 4 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental target a-iTBS treatment and Conventional target a-iTBS treatment in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 2 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: opening soon, as of the sponsor's last update on 4 Mar 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?
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (time frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.