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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT03571412
• Lead Sponsor: Universidad Autonoma de Queretaro

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08-08
• Primary Completion: 2017-07-31
• Study Completion: 2017-09-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5Hz Left Dorsolateral Prefrontal Cortex	repetitive Transcranial Magnetic Stimulation	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.
5Hz Dorsomedial Prefrontal Cortex	repetitive Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS)	3 weeks	Hamilton Depressive Rating Scale (HADRS) is a 21 item clinimetric scale to evaluate severity of depressive symptoms in patients.

Secondary Outcome Measures

Name	Time	Method
Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS)	3 weeks	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.