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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham iTBS combined with antidepressants | Combination Product | Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 4-week post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic response rate and remission rate | Response is defined as a reduction ā„ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17. | immediately post-treatment |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment | The Perceived Deficits Questionnaire - Depression (PDQ-D) is a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression. The PDQ-D is a 20-item questionnaire and the total score ranger from 0 to 80, and higher scores indicate a greater degree of cognitive impairment. THINC-itĀ® is a brief screening tool designed to measure cognition and determine whether cognitive functioning is impaired. Users can complete the cognitive screening in only 10-15 minutes. THINC-itĀ® includes 4 objective cognitive tests (adapted from choice reaction time, 1-back working memory task, symbol digit coding, and Trails-B) and a subjective cognitive questionnaire (PDQ-5). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XijingH | Xi'an | Shaan'xi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41545765 | Derived | Zheng 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. | |
| 39515856 | Derived | Liu 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. |
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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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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| iTBS combined with antidepressants | Combination Product | Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants. |
|
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. |
| 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. | 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. | 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. | baselinećimmediately post treatment and 4-week post-treatment |
| Pre-treatment to immediately post-treatment |
| D020164 | Chemical Actions and Uses |