Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

Study Overview
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Brief Summary
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This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.

Detailed Description
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This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

Official Title
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Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

Conditions
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Depression, Treatment

Intervention / Treatment
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* Device: TBS
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnostic criteria of DSM-IV for MDD The range of the age from 18 to 70-year-old Physically healthy on medical history, physical examination, and laboratory parameters within normal limits Competent for a full explanation of the study and written informed consent is obtained. Exclusion Criteria: Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded Pregnant History or family history of seizure disorder Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Theta-burst stimulation (TBS)<br>Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) | Device: TBS<br>* Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)<br>|
| Sham Comparator: Sham controlled intervention<br>The sham-TBS coil produced a similar sound without a magnetic pulse. | Device: Sham<br>* The sham-TBS coil produced a similar sound without a magnetic pulse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAMD) | The Hamilton Depression scale sum score (HAMD21) Not depressed: 0-7 Mild: 8-13 Moderate: 14-18 Severe: 19-22 Very severe: >23 | From Weeks 0 to 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group. | From Weeks 0 to 24 | 
| Remission rate | The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission. | From Weeks 0 to 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, transcranial magnetic stimulation, theta-burst stimulation