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

NCT03571412 | Completed DMC

• 1 other identifier: 01-05/05/2016
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS)

  3 weeks

Study Arms (2)

5Hz Left Dorsolateral Prefrontal Cortex

EXPERIMENTAL

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

5Hz Dorsomedial Prefrontal Cortex

EXPERIMENTAL

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

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS

Also known as: Transcranial Magnetic Stimulation

5Hz Dorsomedial Prefrontal Cortex; 5Hz Left Dorsolateral Prefrontal Cortex

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old.
• Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder.
• Score \>17 in Hamilton Depression Rating Scale.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Julian Reyes, PhD

  Universidad Autónoma de Querétaro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: June 27, 2018
• Study Start: August 8, 2016
• Primary Completion: July 31, 2017
• Study Completion: September 1, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04