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

Phase 2

• Conditions: Suicidal Ideation; Depression
• Interventions: Combination Product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination Product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination Product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

• Registration Number: NCT04653337
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-11-28
• Study First Posted: 2020-12-04
• Status Verified: 2022-07
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted accelerated iTBS-1800 and Antidepressants	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	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 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).

Primary Outcome Measures

Name	Time	Method
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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).
Change in the Beck Depression Inventory (BDI)	Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment	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.
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	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.

Trial Locations

Locations (1)

XijingH; 🇨🇳 Xi'an, Shaanxi, China