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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04653337
Other study ID # KY20202066-F-1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2020
Est. completion date December 31, 2023

Study information

Verified date July 2022
Source Xijing Hospital
Contact NaiLong TANG
Phone +8618960692506
Email tangfmmu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Combination Product:
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).
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)
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)

Locations

Country Name City State
China XijingH Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Magnetic Resonance Imaging (MRI) resting-state functional MRI Baseline, Within 2 days post-treatment
Other near-infrared imaging technology (fNIRS) task-state fNIRS Baseline, Within 2 days post-treatment
Primary 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 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. Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Secondary 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
Secondary 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
Secondary 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
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