Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study

Study Overview
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Brief Summary
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This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.

Official Title
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Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study

Conditions
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DEPRESSION

Intervention / Treatment
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* Device: Transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years to 75 years Both gender eligible Volontary and able to give consent Major depressive episode (MADRS > 20) single or recurrent Resistance to at least 2 antidepressants , Treated by antidepressant at efficient stable posology since more than 6 weeks Exclusion Criteria: Initiation or modification of antidepressant drug Neurodegenerative diseas Bipolar I, II disorder Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms Substance abuse in past 15 days Substance dependence not weaned Benzodiazepine and any anticonvulsant during rTMS treatment course ECT failure in medical history Contra-indication to rTMS and MRI Pregnancy Difficulty to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Frequency Left repetitive<br>High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100 | Device: Transcranial magnetic stimulation<br> <br> |
| Experimental: intermittent Theta Burst Stimulation (iTBS)<br>intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100 | Device: Transcranial magnetic stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response rate | Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement > 50 % in each group at the end of TMS sessions and one month after. A final score of <8 is categorized as remission. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate |  | 6 months | 
| Quality of life |  | 6 months | 
| Measures of cortical excitability |  | 6 months |