Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
NCT06667180

Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels

Led by Universidad de Guanajuato · Updated on 2025-05-08

40

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

U

Universidad de Guanajuato

Lead Sponsor

I

Instituto Mexicano del Seguro Social

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). TMS works to treat MDD by using low-intensity magnetic fields to modulate certain areas of the brain, activating them which can help improve the mood of those suffering from the disorder. Final metabolites of serotonin such as 5-HIAA and growth factors such as BDNF will also be studied before starting the intervention and at the end to check if there is a significant change in their concentration. Likewise, its safety will be evaluated by monitoring the symptoms that they present at the end of the intervention and one month later. The main questions that are intended to be answered are: * Does low-intensity TMS reduce depressive symptoms in patients with MDD? * Does low-intensity TMS significantly change the initial and final concentrations of 5-HIAA and BDNF? * What adverse effects might patients who are exposed to low-intensity TMS experience? The researchers will compare low-intensity and accelerated TMS with sham TMS to see if low-intensity TMS works to treat MDD. Participants: * Will undergo an initial clinical assessment to confirm the disorder, comorbidities, and general health status. * A 5 mL blood sample will be taken before starting the intervention. * Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 milliTesla (mT) and frequency of 50 Hz in theta bursts. Symptoms will be monitored daily. * A 5 mL blood sample will be taken at the end of the intervention and general health status clinimetrics will be reapplied.

CONDITIONS

Official Title

Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Both sexes
  • Diagnosis of major depressive disorder confirmed by a psychiatrist
  • Continuing current treatment and attending follow-up consultations
  • No history of epilepsy, schizophrenia, or neurosurgeries
  • No metal plates in skull, neck, chest, or shoulder
  • No use of pacemakers
  • Not taking hormone substitutes
  • Agree to participate in the research
Not Eligible

You will not qualify if you...

  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute

León, Guanajuato, Mexico, 37328

Actively Recruiting

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Research Team

O

Olga E Escobar Florez, Master of Medical Sciences

CONTACT

M

Ma. Eugenia Garay Sevilla, Medical Sciences PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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