Back to resultsNeuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
Primary Purpose
Suicidal Ideation, Depression
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicidal Ideation, Depression, Neuronavigation, robot-assisted rTMS, rTMS
Eligibility Criteria
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
Sites / Locations
- XijingHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Robot-assisted accelerated iTBS-1800 and Antidepressants
Robot-assisted accelerated iTBS-600 and Antidepressants
Sham accelerated iTBS-600 and Antidepressants
Arm Description
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.
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04653337
Brief Title
Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
Official Title
Research on Efficacy and Safety of Robot-assisted rTMS Based on Neuroimaging Navigation for the Treatment of Depressive Patients With Suicidal Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Depression
Keywords
Suicidal Ideation, Depression, Neuronavigation, robot-assisted rTMS, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted accelerated iTBS-1800 and Antidepressants
Arm Type
Experimental
Arm Description
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.
Arm Title
Robot-assisted accelerated iTBS-600 and Antidepressants
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Sham accelerated iTBS-600 and Antidepressants
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Combination Product
Intervention Name(s)
Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Intervention Description
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).
Intervention Type
Combination Product
Intervention Name(s)
Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Intervention Description
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）
Intervention Type
Combination Product
Intervention Name(s)
Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Intervention Description
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）
Primary Outcome Measure Information:
Title
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
Description
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.
Time Frame
Pre-treatment to immediately post treatment (on day 5)
Secondary Outcome Measure Information:
Title
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score
Description
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.
Time Frame
Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Title
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Description
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).
Time Frame
Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Title
Change in the Beck Depression Inventory (BDI)
Description
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.
Time Frame
Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Title
Change in the 6-Item Hamilton Rating Scale for Depression (HAMD-6) Score
Description
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.
Time Frame
Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Magnetic Resonance Imaging (MRI)
Description
resting-state functional MRI
Time Frame
Baseline, Within 2 days post-treatment
Title
near-infrared imaging technology (fNIRS)
Description
task-state fNIRS
Time Frame
Baseline, Within 2 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NaiLong TANG
Phone
+8618960692506
Email
tangfmmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HuaNing WANG, PhD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
XijingH
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuaNing WANG, PhD
Email
xskzhu@fmmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
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