Antidepressive Effect on 5 Herz (Hz) rTMS Over Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex

Study Overview
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Brief Summary
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This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD).

Detailed Description
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Major Depressive Disorder (MDD) affects a significant percentage of the national population (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive Disorder and it has demonstrated favorable clinical effects when applied over the Left Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS treatment targets during the presence of MDD, given its association with deficient cognitive processes during the course of the illness. There is also evidence of the use of 5Hz frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz when applied to the LDLPFC. However, there are no current research that have addressed the use of this frequency on DMPFC.

Official Title
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Comparative of Antidepressive Effect on 5Hz rTMS on Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old. Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder. Score >17 in Hamilton Depression Rating Scale. Exclusion Criteria: Subjects with diagnose of Psychotic Depression, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder. Subjects with epilepsy or presence of paroxysms during the EEG. Subjects with previous history of traumatic brain injury, metal plates in the skull, cochlear devices, infusion devices such as insulin pumps.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5Hz Left Dorsolateral Prefrontal Cortex<br>This group will receive 5Hz Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation. Once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. | Device: repetitive Transcranial Magnetic Stimulation<br>* Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS<br>* Other names: Transcranial Magnetic Stimulation;|
| Experimental: 5Hz Dorsomedial Prefrontal Cortex<br>This group will receive 5Hz Dorsomedial Prefrontal Cortex Transcranial Magnetic Stimulation, once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. | Device: repetitive Transcranial Magnetic Stimulation<br>* Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS<br>* Other names: Transcranial Magnetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS) | Hamilton Depressive Rating Scale (HADRS) is a 21 item clinimetric scale to evaluate severity of depressive symptoms in patients. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS) | Montgomery- Asberg Depressive Rating Scale (MADRS) is a 10 item clinimetric scale that evaluates the presence and severity of depressive symptoms in subjects with the disorder mentioned before. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major Depressive Disorder