DepressionPhase 2NCT05577481
Neuronavigation Guided iTBS With Personalized Target for Depression
A Phase 2 study testing iTBS combined with antidepressants in people with Depression, run by Xijing Hospital at 1 site in China.
Trial summary
The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- iTBS combined with antidepressants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 28 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 60 years old
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
- Able to provide informed consent
Who cannot join
- any other current or past psychiatric axis-I or axis-II disorders
- severe physical illnesses
- psychotic symptoms, alcohol or drug abuse
- A history of neurological disorders including seizure, cerebral trauma
- MRI evidence of structural brain abnormalities
- Contraindications to MRI and rTMS
- Acute suicide
- Female that is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder
The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.
- Conditions
- Depression
- Being tested
- sham iTBS combined with antidepressants, iTBS combined with antidepressants
- Keywords
- depression, intermittent Theta Burst Stimulation, neuronavigation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham iTBS combined with antidepressantsCombination product
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
iTBS combined with antidepressantsCombination product
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
| Study group | Role | What they receive |
|---|---|---|
| functional MRI-guided iTBS(sham group) | Sham comparator | The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). Receives: Combination Product: sham iTBS combined with antidepressants |
| functional MRI-guided iTBS (pgACC-DLPFC) | Experimental | The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). Receives: Combination Product: iTBS combined with antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
Measured: baseline and 4-week post treatment
Secondary outcomes (5)
Therapeutic response rate and remission rate
Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17.
Measured: immediately post-treatment
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
MADRS total score comprises a sum of the 10 individual item scores. Each item is rated on a 7 point scale from 0 to 6. The Total Score can range from 0 to 60, and higher scores indicate a greater degree of depression.
Measured: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide.
Measured: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change in the Hamilton Anxiety Scale (HAMA) Score
HAMD total score comprises a sum of the 14 individual item scores. Each item is rated on a 5 point scale from 0 to 4. The Total Score can range from 0 to 56, and higher scores indicate a greater degree of anxiety.
Measured: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change From Baseline Functional Connectivity to Immediately Post-treatment
The change in resting state fMRI functional connectivity of the pgACC to the default mode network and within the default mode network will be assessed.
Measured: baseline、immediately post treatment and 4-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Jul 2023
- Primary completion30 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577481
- Sponsor's protocol ID
- XJLL-KY20222111
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the trial and publication of the relevant paper, the corresponding author can be contacted for individual participant data.
Publications
Zheng K, Zheng X, Shi H, Chen L, Li L; DIRECT consortium; Hu D, Friston KJ, Wang H, Li B, Chen B. Brain contrastive modeling reveals depression subtypes with distinct treatment response and progression. NPJ Digit Med. 2026 Jul 20. doi: 10.1038/s41746-026-03011-8. Online ahead of print.
PubMed 42477489Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.
PubMed 41545765Liu N, Zhao N, Tang N, Cai M, Zhang Y, Lv R, Zhang Y, Han T, Meng Y, Zang Y, Wang H. Safety and efficacy of individual target transcranial magnetic stimulation to stimulate the most negative correlate of DLPFC-pgACC in the treatment of major depressive disorder: study protocol of a double-blind, randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e081520. doi: 10.1136/bmjopen-2023-081520.
PubMed 39515856
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05577481
- Acronym / sponsor ID
- XJLL-KY20222111
- Conditions
- Depression
- Keywords
- depression, intermittent Theta Burst Stimulation, neuronavigation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Oct 2022 (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 study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional MRI-guided iTBS(sham group) | Sham comparator | Combination Product: sham iTBS combined with antidepressantsThe stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). |
| functional MRI-guided iTBS (pgACC-DLPFC) | Experimental | Combination Product: iTBS combined with antidepressantsThe stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 60 years old
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
- Able to provide informed consent
Key exclusion criteria (8 listed)
- any other current or past psychiatric axis-I or axis-II disorders
- severe physical illnesses
- psychotic symptoms, alcohol or drug abuse
- A history of neurological disorders including seizure, cerebral trauma
- MRI evidence of structural brain abnormalities
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 |
|---|---|---|
| sham iTBS combined with antidepressantsTwo sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants. | Combination product | functional MRI-guided iTBS(sham group) |
| iTBS combined with antidepressantsTwo sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants. | Combination product | functional MRI-guided iTBS (pgACC-DLPFC) |
Primary outcome
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
Time frame: baseline and 4-week post treatment
The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
5 secondary outcomes
Therapeutic response rate and remission rate
Time frame: immediately post-treatment
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change in the Hamilton Anxiety Scale (HAMA) Score
Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change From Baseline Functional Connectivity to Immediately Post-treatment
Time frame: baseline、immediately post treatment and 4-week post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42477489Zheng K, Zheng X, Shi H, Chen L, Li L; DIRECT consortium; Hu D, Friston KJ, Wang H, Li B, Chen B. Brain contrastive modeling reveals depression subtypes with distinct treatment response and progression. NPJ Digit Med. 2026 Jul 20. doi: 10.1038/s41746-026-03011-8. Online ahead of print.
- Derived from this study: PubMed 41545765Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.
- Derived from this study: PubMed 39515856Liu N, Zhao N, Tang N, Cai M, Zhang Y, Lv R, Zhang Y, Han T, Meng Y, Zang Y, Wang H. Safety and efficacy of individual target transcranial magnetic stimulation to stimulate the most negative correlate of DLPFC-pgACC in the treatment of major depressive disorder: study protocol of a double-blind, randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e081520. doi: 10.1136/bmjopen-2023-081520.
- Individual participant dataSharing planned: No. After completion of the trial and publication of the relevant paper, the corresponding author can be contacted for individual participant data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iTBS combined with antidepressants in people with Depression, run by Xijing Hospital 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 27 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment (time frame: baseline and 4-week post treatment). 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 NCT05577481, which also lists 3 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 27 Apr 2026.