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There is relatively insufficient evidence on whether rTMS can improve suicidal ideation in depressive patients. And existing studies have been inconsistent in the treatment of depressive suicidal thoughts. The possible reason is inaccurate stimuli localization. Improving the accuracy of rTMS stimulus positioning may further improve the intervention effect of suicidal ideation. This study will introduce an automated TMS system with robot control and optical sensor combined with neuronavigation softwarea. By using the robot based on neuronavigation system, the rTMS coil can be accurately positioned over any preselected brain region. An infrared optical measurement device is also used in order to detect and compensate for head movements of the patient. The purpose of this randomized double-blind and sham-controlled study is to test the efficacy and safety of robot-assisted rTMS based on neuronavigation in the treatment of depressive suicidal ideation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted accelerated iTBS-1800 and Antidepressants | Experimental | MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-1800(10 sessions per day over 5 consecutive days). This group is in order to determine the safety, tolerability and feasibility of accelerated iTBS protocol. |
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| Robot-assisted accelerated iTBS-600 and Antidepressants | Active Comparator | MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-600(6 sessions of iTBS with 30 min interval per day over 5 consecutive days). |
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| Sham accelerated iTBS-600 and Antidepressants | Sham Comparator | MDD patients with suicidal ideation and depression will receive antidepressants combined with sham accelerated iTBS-600(6 sessions of sham iTBS with 30 min interval per day over 5 consecutive days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) | Combination Product | Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-1800 (10 sessions of iTBS1800 with 50 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score | Outcome measured by a change in BSI-CV score from baseline to 4 weeks post-treatment. 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 scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide. | Pre-treatment to immediately post treatment (on day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score | Outcome measured by a change in HAMD-17 score from baseline to 4 weeks post-treatment.The HAMD Total Score comprises a sum of the 17 individual item scores. Each item is rated on a 3 point scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Response is defined as having a 50% or greater reduction from baseline in HAMD total score. Remission is defined as having a HAMD total score of ≤7. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | resting-state functional MRI | Baseline, Within 2 days post-treatment |
| near-infrared imaging technology (fNIRS) | task-state fNIRS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NaiLong TANG | Contact | +8618960692506 | tangfmmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| HuaNing WANG, PhD | Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XijingH | Recruiting | 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. |
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|
| Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) | Combination Product | Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-600 (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine） |
|
| Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) | Combination Product | Subjects will receive a 5-day trial of sham accelerated iTBS (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine） |
|
| Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Outcome measured by a change in MADRS score from baseline to 4 weeks post-treatment. The MADRS is a 10-item, clinician-rated questionnaire used to evaluate the severity of depression. Each item is rated on a scale from 0-6.4,5 Scores are then summed to yield a total score ranging from 0 (none/absent) to 60 (most severe). | Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment |
| Change in the Beck Depression Inventory (BDI) | Outcome measured by a change in BDI score from baseline to 4 weeks post-treatment. The BDI-II is a 21-item, self-rated scale that assesses the severity of depressive symptoms.Items are rated according to severity on a 0-3 scale, with the exception of two items rated on a 0-6 scale.The BDI is scored by simple addition and has a maximum total score of 63 .Higher total scores indicate more severe depressive symptoms. | Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment |
| Change in the 6-Item Hamilton Rating Scale for Depression (HAMD-6) Score | HAMD-6 is a shorter version of the HAMD-17 scale which measures only depressed mood (item 1), feeling of guilt (item 2), work and activities (item 7), motor retardation (item 8), psychic anxiety (item 10), and somatic symptoms (general) (item 13). Higher total scores indicate more severe depressive symptoms. | Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment |
| Baseline, Within 2 days post-treatment |
| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068760 | Serotonin and Noradrenaline Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D045505 | Physiological Effects of Drugs |
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