Major Depressive Disorder (MDD)NCT07743398
Context-Guided Personalized iTBS for Depression
A study testing Context-Guided Personalized Intermittent Theta Burst Stimulation and Standard Left DLPFC Intermittent Theta Burst Stimulation in people with Major Depressive Disorder (MDD), run by Capital Medical University at 1 site in China.
Trial summary
The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Context-Guided Personalized Intermittent Theta Burst Stimulation and Standard Left DLPFC Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to 30 Oct 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
- Right-handed.
- Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
- A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
- At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
- At least primary school education and able to understand the study procedures and requirements.
- Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely.
- Voluntarily agrees to participate and provides written informed consent.
Who cannot join
- Serious or unstable medical or neurological illness.
- Pregnancy or breastfeeding.
- History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
- Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
- Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
- Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
- Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.
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
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, 100088
Zhi Yang, PhD, +8618611710840, yangz@mail.ccmu.edu.cn
About this study
Official title: Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging
The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.
Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.
Read more
Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.
The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.
Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Context-Guided Personalized Intermittent Theta Burst Stimulation, Standard Left DLPFC 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.
Context-Guided Personalized Intermittent Theta Burst StimulationDevice
An individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data. Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target. Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Standard Left DLPFC Intermittent Theta Burst StimulationDevice
Intermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex. Before each stimulation session, the participant watches a neutral video. Stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
| Study group | Role | What they receive |
|---|---|---|
| Context-Guided Personalized iTBS | Experimental | Participants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS). An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data. Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold. Receives: Device: Context-Guided Personalized Intermittent Theta Burst Stimulation |
| Standard Left DLPFC iTBS | Active comparator | Participants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Before each iTBS session, participants will watch a neutral video. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold. Receives: Device: Standard Left DLPFC Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up. The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms. Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
Measured: At 2 weeks after completion of treatment (Day 21 ± 2 days).
Secondary outcomes (5)
Early Treatment Response Rate Based on HAMD-17
Early treatment response is defined as a reduction of at least 20% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) immediately after completion of the treatment intervention. The outcome will be summarized as the proportion of participants meeting this response criterion in each treatment arm. Lower HAMD-17 scores indicate fewer depressive symptoms. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
Measured: Baseline to immediately after completion of the treatment intervention
Change From Baseline in HAMD-17 Factor Scores
Changes from baseline in the prespecified factor scores of the 17-item Hamilton Depression Rating Scale (HAMD-17) will be assessed at the 2-week follow-up. For each factor, the change score will be calculated as the follow-up score minus the baseline score. A greater reduction indicates greater improvement in the corresponding depressive symptom domain. The HAMD-17 consists of 17 items; 9 items are scored from 0 to 4 and 8 items are scored from 0 to 2. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change is calculated as the post-baseline score minus the baseline score; negative values indicate improvement.
Measured: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in QIDS-SR16 Total Score
Changes from baseline in the total score of the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. Lower scores indicate fewer self-reported depressive symptoms. The QIDS-SR16 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in HAMA Total Score
Changes from baseline in the total score of the Hamilton Anxiety Rating Scale (HAMA) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. The HAMA is a clinician-rated measure of anxiety symptom severity, with lower scores indicating fewer anxiety symptoms. The 14-item HAMA total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Incidence of Adverse Events
The number and proportion of participants experiencing one or more adverse events will be recorded for each treatment arm. Adverse events may include headache, scalp discomfort, muscle twitching, transient mood changes, or other adverse events occurring during the treatment and follow-up periods.
Measured: From the first treatment session through the 2-week follow-up after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Yang, Capital Medical University
- Investigators
- Zhi Yang, PhD, Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743398
- Sponsor's protocol ID
- BRWEP2024W072120106
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only. Study data will be stored and analyzed on a secure internal institutional server.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging
- ClinicalTrials.gov ID
- NCT07743398
- Acronym / sponsor ID
- BRWEP2024W072120106
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 3 Aug 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.
The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.
Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.
Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.
The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.
Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Context-Guided Personalized iTBS | Experimental | Device: Context-Guided Personalized Intermittent Theta Burst StimulationParticipants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS). An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data. Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold. |
| Standard Left DLPFC iTBS | Active comparator | Device: Standard Left DLPFC Intermittent Theta Burst StimulationParticipants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Before each iTBS session, participants will watch a neutral video. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
- Right-handed.
- Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
- A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
- At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
Key exclusion criteria (7 listed)
- Serious or unstable medical or neurological illness.
- Pregnancy or breastfeeding.
- History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
- Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
- Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
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 |
|---|---|---|
| Context-Guided Personalized Intermittent Theta Burst StimulationAn individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data. Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target. Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. | Device | Context-Guided Personalized iTBS |
| Standard Left DLPFC Intermittent Theta Burst StimulationIntermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex. Before each stimulation session, the participant watches a neutral video. Stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. | Device | Standard Left DLPFC iTBS |
Primary outcome
Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
Time frame: At 2 weeks after completion of treatment (Day 21 ± 2 days).
The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up. The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms. Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
5 secondary outcomes
Early Treatment Response Rate Based on HAMD-17
Time frame: Baseline to immediately after completion of the treatment intervention
Change From Baseline in HAMD-17 Factor Scores
Time frame: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in QIDS-SR16 Total Score
Time frame: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in HAMA Total Score
Time frame: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Incidence of Adverse Events
Time frame: From the first treatment session through the 2-week follow-up after completion of treatment
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 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only. Study data will be stored and analyzed on a secure internal institutional server.
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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.
Zhi Yang, PhD principal investigator
Beijing Anding Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Context-Guided Personalized Intermittent Theta Burst Stimulation and Standard Left DLPFC Intermittent Theta Burst Stimulation in people with Major Depressive Disorder (MDD), run by Capital 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 8 inclusion and 7 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 5 Aug 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. 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 Zhi Yang, PhD (+86 186 1171 0840, yangz@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response Rate at 2-Week Follow-up Based on HAMD-17 (time frame: At 2 weeks after completion of treatment (Day 21 ± 2 days).). 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 5 Aug 2026.