Neuronavigation Guided iTBS With Personalized Target for Depression

Study Overview
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Brief Summary
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The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Official Title
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Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder

Conditions
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Depression

Intervention / Treatment
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* Combination Product: sham iTBS combined with antidepressants
* Combination Product: iTBS combined with antidepressants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 60 years old Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits Able to provide informed consent Exclusion Criteria: any other current or past psychiatric axis-I or axis-II disorders severe physical illnesses psychotic symptoms, alcohol or drug abuse A history of neurological disorders including seizure, cerebral trauma MRI evidence of structural brain abnormalities Contraindications to MRI and rTMS Acute suicide Female that is pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: functional MRI-guided iTBS(sham group)<br>The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). | Combination Product: sham iTBS combined with antidepressants<br>* Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.<br>|
| Experimental: functional MRI-guided iTBS (pgACC-DLPFC)<br>The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6). | Combination Product: iTBS combined with antidepressants<br>* Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment | The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. | baseline and 4-week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response rate and remission rate | Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17. | immediately post-treatment | 
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | MADRS total score comprises a sum of the 10 individual item scores. Each item is rated on a 7 point scale from 0 to 6. The Total Score can range from 0 to 60, and higher scores indicate a greater degree of depression. | baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment | 
| Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score | 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 score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide. | baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment | 
| Change in the Hamilton Anxiety Scale (HAMA) Score | HAMD total score comprises a sum of the 14 individual item scores. Each item is rated on a 5 point scale from 0 to 4. The Total Score can range from 0 to 56, and higher scores indicate a greater degree of anxiety. | baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment | 
| Change From Baseline Functional Connectivity to Immediately Post-treatment | The change in resting state fMRI functional connectivity of the pgACC, NAc to the default mode network and within the default mode network will be assessed. | baseline and immediately post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, intermittent Theta Burst Stimulation, neuronavigation