Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression

NCT04653337 | Unknown Phase 2

• 1 other identifier: KY20202066-F-1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Suicidal Ideation; Depression; Neuronavigation; robot-assisted rTMS; rTMS

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score

  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

  Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment

• Change in the Beck Depression Inventory (BDI)

  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

  Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment

Other Outcomes (2)

• Magnetic Resonance Imaging (MRI)

  Baseline, Within 2 days post-treatment

• near-infrared imaging technology (fNIRS)

  Baseline, Within 2 days post-treatment

Study Arms (3)

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.

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).

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).

Combination Product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

Interventions

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-1800 and Antidepressants

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）

Robot-assisted accelerated iTBS-600 and Antidepressants

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）

Sham accelerated iTBS-600 and Antidepressants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingH

Xi'an, Shaan'xi, 710032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41545765 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Depression

Interventions

Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Physiological Effects of Drugs

Study Officials

• HuaNing WANG, PhD

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

NaiLong TANG

CONTACT

+8618960692506; tangfmmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 4, 2020
• Study Start: September 28, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)