Neuronavigation Guided iTBS With Personalized Target for Depression
Study Details
Study Description
Brief Summary
The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with different stimulated targets for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on anatomy structure and functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols have a superiority antidepressant efficacy compared to anatomy structure targeted one.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: structural MRI-guided iTBS The stimulating site of the left DLPFC is targeted based on structural MRI and the MNI coordinate is (-41, 16, 54). |
Combination Product: iTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
|
| Experimental: functional MRI-guided iTBS (pgACC-DLPFC) 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
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
|
| Experimental: functional MRI-guided iTBS (NAc-DLPFC) The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left NAc. The MNI coordinate is (-9, 9, -8). |
Combination Product: iTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
|
Outcome Measures
Primary Outcome Measures
- Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment [baseline and 4-week 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.
Secondary Outcome Measures
- Therapeutic response rate and remission rate [immediately post-treatment]
Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17.
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score [baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment]
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.
- Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score [baseline, immediately post-treatment and 2-week, 4-week and 8-week 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 score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide.
- Change in the Hamilton Anxiety Scale (HAMA) Score [baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment]
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.
- Change From Baseline Functional Connectivity to Immediately Post-treatment [baseline and 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.
Other Outcome Measures
- Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment [Pre-treatment to immediately post-treatment]
The Perceived Deficits Questionnaire - Depression (PDQ-D) is a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression. The PDQ-D is a 20-item questionnaire and the total score ranger from 0 to 80, and higher scores indicate a greater degree of cognitive impairment. THINC-it® is a brief screening tool designed to measure cognition and determine whether cognitive functioning is impaired. Users can complete the cognitive screening in only 10-15 minutes. THINC-it® includes 4 objective cognitive tests (adapted from choice reaction time, 1-back working memory task, symbol digit coding, and Trails-B) and a subjective cognitive questionnaire (PDQ-5).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 60 years old
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Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
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Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
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Able to provide informed consent
Exclusion Criteria:
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any other current or past psychiatric axis-I or axis-II disorders
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severe physical illnesses
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psychotic symptoms, alcohol or drug abuse
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A history of neurological disorders including seizure, cerebral trauma
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MRI evidence of structural brain abnormalities
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Contraindications to MRI and rTMS
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Acute suicide
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Female that is pregnant or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | XijingH | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJLL-KY20222111