Personalized Accelerated iTBS Versus Sham for Major Depressive Disorder (iTBS-MDD)

September 21, 2026 updated by: Gang Wang, Capital Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active: Accelerated iTBS

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.
Device: Personalized Functional-Connectivity-Targeted Accelerated iTBS

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 Comparator: Sham: Accelerated iTBS

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.
Device: Sham Accelerated iTBS

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).

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
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).

Proportion of participants achieving remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 10 or lower.
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 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.
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 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.
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 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.
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 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
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).

The Clinical Global Impression (CGI) will be used to assess overall changes in participants' clinical condition and treatment response throughout the study.
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 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.
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).

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.
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).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events and Serious Adverse Events
Time Frame: From the first stimulation session on Treatment Day 1 through 8 weeks post-treatment (Week 8; Day 62).

Relevant information will be collected through active inquiry, participant self-reports, clinical observation, and necessary medical examinations.
From the first stimulation session on Treatment Day 1 through 8 weeks post-treatment (Week 8; Day 62).
Emergence or Worsening of Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia-Suicide Severity Rating Scale
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).

Occurrence or worsening of suicidal ideation or suicidal behavior assessed using the Columbia-Suicide Severity Rating Scale. Outcomes include newly emergent or increased suicidal ideation, suicidal intent, suicidal planning, suicidal behavior, or an increased level of suicide risk compared with baseline.
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).
Emergence or Worsening of Manic Symptoms Assessed by the Young Mania Rating Scale
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).

The Young Mania Rating Scale (YMRS) will be used as a safety measure to monitor the emergence or worsening of manic symptoms during and after treatment. The total score ranges from 0 to 60, with higher scores indicating greater severity of manic symptoms.
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 Transcranial Magnetic Stimulation-Evoked Potentials
Time Frame: Screening (Day -8), pre-treatment baseline (Day -1), after completion of the tenth stimulation session on treatment Day 3 (Day 3), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), and 4 weeks post-treatment (Week 4; Day 34).

Change in the amplitude and latency of transcranial magnetic stimulation-evoked electroencephalographic potential components, including the N45 and N100 components, following stimulation of the left dorsolateral prefrontal cortex. These measures assess cortical excitation-inhibition balance and neuroplasticity.
Screening (Day -8), pre-treatment baseline (Day -1), after completion of the tenth stimulation session on treatment Day 3 (Day 3), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), and 4 weeks post-treatment (Week 4; Day 34).
Change in MRI-Derived Neuroimaging Measures
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), and 8 weeks post-treatment (Week 8; Day 62).

Changes in prespecified resting-state functional MRI-derived functional connectivity measures from baseline to each post-treatment assessment. These measures will include functional connectivity between the left dorsolateral prefrontal cortex target and the subgenual anterior cingulate cortex (sgACC), functional connectivity within the default mode network (DMN), functional connectivity between the sgACC and the DMN,and functional connectivity between the DLPFC and the DMN.
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), and 8 weeks post-treatment (Week 8; Day 62).
Change in Resting-State Electroencephalography Measures
Time Frame: Screening (Day -8), pre-treatment baseline (Day -1), after completion of the tenth stimulation session on treatment Day 3 (Day 3), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), and 4 weeks post-treatment (Week 4; Day 34).

Changes in prespecified measures derived from resting-state electroencephalography (EEG). These measures will include frontal alpha asymmetry, alpha-band current source density, the aperiodic 1/f slope, and EEG spectral characteristics. These exploratory measures will be used to evaluate treatment-related changes in electrophysiological activity and their associations with clinical outcomes.
Screening (Day -8), pre-treatment baseline (Day -1), after completion of the tenth stimulation session on treatment Day 3 (Day 3), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), and 4 weeks post-treatment (Week 4; Day 34).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026(43)
  • YG202603, 3-1-99-2026-pt22 (Other Grant/Funding Number: Beijing Anding Hospital, Capital Medical University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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