Major Depressive Disorder (MDD)iTBS-MDDNCT07843875
Personalized Accelerated iTBS Versus Sham for Major Depressive Disorder
A study testing Personalized Functional-Connectivity-Targeted Accelerated iTBS in people with Major Depressive Disorder (MDD), run by Capital Medical University.
Trial summary
This randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Personalized Functional-Connectivity-Targeted Accelerated iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 31 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 22 to 65 years, regardless of sex. Right-handed.
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, confirmed using the Mini International Neuropsychiatric Interview (MINI), version 7.0.The current major depressive episode has lasted for at least 4 weeks.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 20 or greater at both screening and baseline.
- Stable depressive symptoms, defined as a difference in MADRS total score between screening and baseline of no more than 20%.
- Currently medication-free or receiving a stable dose of psychiatric medication for at least 4 weeks before enrollment, with agreement to maintain the same medication regimen through the Week 4 follow-up.
- Able to provide a complete and verifiable history of previous antidepressant treatments.
Show all 9Show fewer
- Eligible to undergo magnetic resonance imaging (MRI).
- Able to complete all protocol-specified resting-state electroencephalography (EEG) and transcranial magnetic stimulation-electroencephalography (TMS-EEG) assessments.
- Able to understand and comply with the study procedures and provide written informed consent.
Who cannot join
- Current or previous diagnosis of bipolar disorder, a psychotic disorder, primary obsessive-compulsive disorder, post-traumatic stress disorder, or another psychiatric disorder considered incompatible with study participation.
- A response of "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the current depressive episode; suicidal behavior within the 6 months before screening; or current high suicide risk as determined by the investigator.
- A change of more than 20% in MADRS total score between screening and baseline.
- A skull defect or fracture, treatment-resistant epilepsy, brain tumor, stroke, or another serious medical or neurological condition that may affect study participation or safety.
- A cardiac pacemaker, cochlear implant, MRI-incompatible metallic foreign body, implanted electronic device, claustrophobia, or another contraindication to MRI or transcranial magnetic stimulation.
- Pregnant or breastfeeding.
Show all 9Show fewer
- Participation in another drug or medical-device clinical trial within 1 month before screening.
- Receipt of electroconvulsive therapy, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, deep brain stimulation, light therapy, or another systematic neuromodulation treatment within 1 month before screening.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Personalized Functional-Connectivity-Targeted Accelerated Intermittent Theta-Burst Stimulation Versus Sham for Major Depressive Disorder
This randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). A total of 90 participants will be randomly assigned in a 1:1 ratio to receive either active iTBS or matched sham stimulation. Treatment will be administered over 5 consecutive days, with 10 stimulation sessions per day.
For each participant, an individualized stimulation target within the left dorsolateral prefrontal cortex will be identified using resting-state functional magnetic resonance imaging (MRI). The primary objective is to compare the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34) between the active and sham groups. Changes in other clinical symptoms, treatment response, remission, and safety will also be assessed during follow-up through 8 weeks after treatment.
Multimodal MRI, resting-state electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG) will be collected at prespecified time points. These measures will be used to explore treatment-related changes in brain function and connectivity and to identify potential neuroimaging and neurophysiological biomarkers associated with clinical improvement and the maintenance of treatment effects.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Personalized Functional-Connectivity-Targeted Accelerated iTBS, Sham Accelerated iTBS
- Keywords
- accelerated iTBS, functional connectivity targeting, DLPFC, personalized neuromodulation
- 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.
Personalized Functional-Connectivity-Targeted Accelerated iTBSDevice
Personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation delivered to the left dorsolateral prefrontal cortex. The stimulation target is individualized using resting-state functional MRI. The active treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 total pulses, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval.
Sham Accelerated iTBSDevice
Sham accelerated intermittent theta-burst stimulation delivered using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule as the active intervention. The sham system is designed to match coil positioning, acoustic click, and scalp sensation, while delivering no effective cortical magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| Active: Accelerated iTBS | Experimental | Participants in this arm will receive personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex. The treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 pulses total, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval. Receives: Device: Personalized Functional-Connectivity-Targeted Accelerated iTBS |
| Sham: Accelerated iTBS | Sham comparator | Participants in this arm will receive sham accelerated intermittent theta-burst stimulation using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule. The sham system is designed to match coil positioning, sound, and scalp sensation, while delivering no effective cortical magnetic field. Receives: Device: Sham Accelerated iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit)
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit). The MADRS assesses the severity of depressive symptoms, with higher scores indicating greater severity. A greater reduction indicates greater improvement in depressive symptoms
Measured: Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)
Secondary outcomes (9)
Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
Proportion of participants with a clinical response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from pre-treatment baseline
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
Proportion of participants achieving remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 10 or lower.
Measured: 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change From Pre-treatment baseline (Day -1) in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Follow-up Visits
Change in MADRS total score from Pre-treatment baseline (Day -1) to each specified follow-up visit. The MADRS total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms. A greater reduction from baseline indicates greater improvement.
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in the 30-Item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30) Total Score
Change in self-reported depressive symptom severity assessed using the IDS-SR30. Higher scores indicate greater depressive symptom severity. A greater reduction from pre-treatment baseline (Day -1) indicates greater improvement.
Measured: Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in 17-item Hamilton Depression Rating Scale (HAM-D-17) Total Score
Change in clinician-rated depressive symptom severity assessed using the HAM-D-17. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. A greater reduction from pre-treatment baseline (Day -1) indicates greater improvement.
Measured: Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
Change in SHAPS total score from baseline to each follow-up visit. The SHAPS is a 14-item self-reported measure of hedonic capacity and anhedonia. Higher scores indicate greater anhedonia, and a reduction from Pre-treatment baseline (Day -1) indicates improvement
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Clinical Global Impression (CGI) Score
The Clinical Global Impression (CGI) will be used to assess overall changes in participants' clinical condition and treatment response throughout the study.
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Change in PSQI total score from baseline to each follow-up visit. The PSQI assesses subjective sleep quality and sleep disturbance. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A reduction from baseline indicates improvement.
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores
Change in the MCCB overall composite score and prespecified cognitive-domain scores from baseline. The MCCB assesses processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Higher scores indicate better cognitive performance.
Measured: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843875
- Sponsor's protocol ID
- 2026(43)
- Other IDs
- YG202603, 3-1-99-2026-pt22
- Acronym
- iTBS-MDD
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
PubMed 33243615Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.
PubMed 22658708Cash RFH, Cocchi L, Lv J, Wu Y, Fitzgerald PB, Zalesky A. Personalized connectivity-guided DLPFC-TMS for depression: Advancing computational feasibility, precision and reproducibility. Hum Brain Mapp. 2021 Sep;42(13):4155-4172. doi: 10.1002/hbm.25330. Epub 2021 Feb 5.
PubMed 33544411Taylor JJ, Kare MR, Haj-Darwish D, Jones E, Sanderson L, Khosravani S, Leach J, Bomer L, Hall N, Chiulli N, Steuber E, Lin C, Drew W, Palm ST, Chandra A, Frandsen SB, Bekou A, Barbour T, Baratono SR, Gonsalvez I, Lyndon S, Schaper FLWVJ, Wang W, Silbersweig D, Siddiqi SH, Fox MD. Connectivity- vs Scalp-Based Targeting of Accelerated Transcranial Magnetic Stimulation for Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Aug 1;83(8):807-817. doi: 10.1001/jamapsychiatry.2026.1100.
PubMed 42340706Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.
PubMed 34711062Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
PubMed 32252538
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Functional-Connectivity-Targeted Accelerated Intermittent Theta-Burst Stimulation Versus Sham for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07843875
- Acronym / sponsor ID
- iTBS-MDD / 2026(43)
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- accelerated iTBS, functional connectivity targeting, DLPFC, personalized neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 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 randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). A total of 90 participants will be randomly assigned in a 1:1 ratio to receive either active iTBS or matched sham stimulation. Treatment will be administered over 5 consecutive days, with 10 stimulation sessions per day.
For each participant, an individualized stimulation target within the left dorsolateral prefrontal cortex will be identified using resting-state functional magnetic resonance imaging (MRI). The primary objective is to compare the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34) between the active and sham groups. Changes in other clinical symptoms, treatment response, remission, and safety will also be assessed during follow-up through 8 weeks after treatment.
Multimodal MRI, resting-state electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG) will be collected at prespecified time points. These measures will be used to explore treatment-related changes in brain function and connectivity and to identify potential neuroimaging and neurophysiological biomarkers associated with clinical improvement and the maintenance of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: Accelerated iTBS | Experimental | Device: Personalized Functional-Connectivity-Targeted Accelerated iTBSParticipants in this arm will receive personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex. The treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 pulses total, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval. |
| Sham: Accelerated iTBS | Sham comparator | Device: Sham Accelerated iTBSParticipants in this arm will receive sham accelerated intermittent theta-burst stimulation using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule. The sham system is designed to match coil positioning, sound, and scalp sensation, while delivering no effective cortical magnetic field. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 22 to 65 years, regardless of sex. Right-handed.
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, confirmed using the Mini International Neuropsychiatric Interview (MINI), version 7.0.The current major depressive episode has lasted for at least 4 weeks.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 20 or greater at both screening and baseline.
- Stable depressive symptoms, defined as a difference in MADRS total score between screening and baseline of no more than 20%.
- Currently medication-free or receiving a stable dose of psychiatric medication for at least 4 weeks before enrollment, with agreement to maintain the same medication regimen through the Week 4 follow-up.
Key exclusion criteria (9 listed)
- Current or previous diagnosis of bipolar disorder, a psychotic disorder, primary obsessive-compulsive disorder, post-traumatic stress disorder, or another psychiatric disorder considered incompatible with study participation.
- A response of "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the current depressive episode; suicidal behavior within the 6 months before screening; or current high suicide risk as determined by the investigator.
- A change of more than 20% in MADRS total score between screening and baseline.
- A skull defect or fracture, treatment-resistant epilepsy, brain tumor, stroke, or another serious medical or neurological condition that may affect study participation or safety.
- A cardiac pacemaker, cochlear implant, MRI-incompatible metallic foreign body, implanted electronic device, claustrophobia, or another contraindication to MRI or transcranial magnetic stimulation.
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 |
|---|---|---|
| Personalized Functional-Connectivity-Targeted Accelerated iTBSPersonalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation delivered to the left dorsolateral prefrontal cortex. The stimulation target is individualized using resting-state functional MRI. The active treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 total pulses, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval. | Device | Active: Accelerated iTBS |
| Sham Accelerated iTBSSham accelerated intermittent theta-burst stimulation delivered using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule as the active intervention. The sham system is designed to match coil positioning, acoustic click, and scalp sensation, while delivering no effective cortical magnetic field. | Device | Sham: Accelerated iTBS |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit)
Time frame: Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit). The MADRS assesses the severity of depressive symptoms, with higher scores indicating greater severity. A greater reduction indicates greater improvement in depressive symptoms
9 secondary outcomes
Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
Time frame: 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change From Pre-treatment baseline (Day -1) in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Follow-up Visits
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in the 30-Item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30) Total Score
Time frame: Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in 17-item Hamilton Depression Rating Scale (HAM-D-17) Total Score
Time frame: Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Clinical Global Impression (CGI) Score
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores
Time frame: Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).
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 28 Sep 2026.
- Background: PubMed 33243615Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
- Background: PubMed 22658708Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.
- Background: PubMed 33544411Cash RFH, Cocchi L, Lv J, Wu Y, Fitzgerald PB, Zalesky A. Personalized connectivity-guided DLPFC-TMS for depression: Advancing computational feasibility, precision and reproducibility. Hum Brain Mapp. 2021 Sep;42(13):4155-4172. doi: 10.1002/hbm.25330. Epub 2021 Feb 5.
- Background: PubMed 42340706Taylor JJ, Kare MR, Haj-Darwish D, Jones E, Sanderson L, Khosravani S, Leach J, Bomer L, Hall N, Chiulli N, Steuber E, Lin C, Drew W, Palm ST, Chandra A, Frandsen SB, Bekou A, Barbour T, Baratono SR, Gonsalvez I, Lyndon S, Schaper FLWVJ, Wang W, Silbersweig D, Siddiqi SH, Fox MD. Connectivity- vs Scalp-Based Targeting of Accelerated Transcranial Magnetic Stimulation for Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Aug 1;83(8):807-817. doi: 10.1001/jamapsychiatry.2026.1100.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Functional-Connectivity-Targeted Accelerated iTBS in people with Major Depressive Disorder (MDD), run by Capital Medical University.
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 9 inclusion and 9 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Adam Williamson, PhD (8615026544105, full.field.hammer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit) (time frame: Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)). 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 NCT07843875, which also lists 6 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 28 Sep 2026.