Suicidal IdeationPhase 2NCT04653337
Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
A Phase 2 study testing Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) and Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) in people with Suicidal Ideation and Depression, run by Xijing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suicidal Ideation, Depression
- What is being tested?
- Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) and Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2020to 31 Dec 2023
- 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
- 18-60 years
- meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- have a score > 17 on the HAMD-17
- have a score ≥ 6 on the BSI-CV
- right- handedness
- physical examination, medical history, vital signs, blood routine, liver and kidney function, ECG, EEG and other indicators are normal
- are voluntary and competent to consent to treatment
Who cannot join
- People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
- Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
- Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
- Acute suicide
- have psychotic symptoms and need to use antipsychotic drugs
- receive ECT treatment within 2 months
- pregnant, breastfeeding or planning to become pregnant during the trial
- refuses to sign the consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XijingH
Xi'an, Shaan'xi, 710032
HuaNing WANG, PhD, xskzhu@fmmu.edu.cn
About this study
Official title: Research on Efficacy and Safety of Robot-assisted rTMS Based on Neuroimaging Navigation for the Treatment of Depressive Patients With Suicidal Ideation
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.
- Conditions
- Suicidal Ideation, Depression
- Being tested
- Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs), Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs), Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
- Keywords
- Suicidal Ideation, Depression, Neuronavigation, robot-assisted rTMS, rTMS
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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）
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) |
| 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). Receives: Combination Product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) |
| 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). Receives: Combination Product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment to immediately post treatment (on day 5)
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start28 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HuaNing WANG, PhD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653337
- Sponsor's protocol ID
- KY20202066-F-1
- Status last verified
- Jul 2022
- First submitted
- 28 Nov 2020
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41545765
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Efficacy and Safety of Robot-assisted rTMS Based on Neuroimaging Navigation for the Treatment of Depressive Patients With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT04653337
- Acronym / sponsor ID
- KY20202066-F-1
- Conditions
- Suicidal Ideation, Depression
- Keywords
- Suicidal Ideation, Depression, Neuronavigation, robot-assisted rTMS, rTMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted accelerated iTBS-1800 and Antidepressants | Experimental | Combination Product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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. |
| Robot-assisted accelerated iTBS-600 and Antidepressants | Active comparator | Combination Product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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). |
| Sham accelerated iTBS-600 and Antidepressants | Sham comparator | Combination Product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years
- meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- have a score > 17 on the HAMD-17
- have a score ≥ 6 on the BSI-CV
- right- handedness
Key exclusion criteria (8 listed)
- People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
- Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
- Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
- Acute suicide
- have psychotic symptoms and need to use antipsychotic drugs
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 |
|---|---|---|
| Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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). | Combination product | Robot-assisted accelerated iTBS-1800 and Antidepressants |
| Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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） | Combination product | Robot-assisted accelerated iTBS-600 and Antidepressants |
| Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)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） | Combination product | Sham accelerated iTBS-600 and Antidepressants |
Primary outcome
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
Time frame: Pre-treatment to immediately post treatment (on day 5)
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.
4 secondary outcomes
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score
Time frame: 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
Time frame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Change in the Beck Depression Inventory (BDI)
Time frame: 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
Time frame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- 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.
- Individual participant dataSharing planned: No
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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.
HuaNing WANG, PhD study chair
Xijing Hospital
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 Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) and Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs) in people with Suicidal Ideation and 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 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NaiLong TANG (+8618960692506, tangfmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score (time frame: Pre-treatment to immediately post treatment (on day 5)). 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 NCT04653337, which also lists 2 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 5 Apr 2023.