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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571412
• Other study ID #: 01-05/05/2016
• Status: Completed
• Phase: N/A
• Start date: August 8, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2019
• Source: Universidad Autonoma de Queretaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 1, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation
Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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