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

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ClinicalTrials.gov Identifier: NCT03571412
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Julian Reyes López, 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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: repetitive Transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Official Title: Comparative of Antidepressive Effect on 5Hz rTMS on Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: 5Hz Left Dorsolateral Prefrontal Cortex
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
Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS
Other Name: Transcranial Magnetic Stimulation

Experimental: 5Hz Dorsomedial Prefrontal Cortex
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
Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS
Other Name: Transcranial Magnetic Stimulation




Primary Outcome Measures :
  1. Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS) [ Time Frame: 3 weeks ]
    Hamilton Depressive Rating Scale (HADRS) is a 21 item clinimetric scale to evaluate severity of depressive symptoms in patients.


Secondary Outcome Measures :
  1. Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571412


Sponsors and Collaborators
Universidad Autonoma de Queretaro
Investigators
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Study Director: Julian Reyes, PhD Universidad Autónoma de Querétaro

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Responsible Party: Dr. Julian Reyes López, Professor, Universidad Autonoma de Queretaro
ClinicalTrials.gov Identifier: NCT03571412     History of Changes
Other Study ID Numbers: 01-05/05/2016
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Julian Reyes López, Universidad Autonoma de Queretaro:
Depression
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs