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NCT Number: NCT06667180

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

León, Guanajuato, 37328, Mexico

Location status: Recruiting

Location contact

Blanca O Murillo Ortíz, PhD Medical Sciences

CONTACT

[email protected]

4772522013

Blanca O Murillo Ortíz, PhD in medical sciences

PRINCIPAL_INVESTIGATOR

Olga E Escobar Florez, Master of Medical Sciences

CONTACT

[email protected]

+524773703795

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 60 years.
  • Both sexes.
  • Those who have a diagnosis of MDD previously made by the treating psychiatrist (considering time since diagnosis and recurrence of episodes).
  • Those who continue with their respective treatment and attend follow-up consultations at the health facility.
  • Those who do not have a history of epilepsy, schizophrenia, neurosurgeries.
  • Those who do not have metal plates anywhere in the skull, neck, chest and shoulder.
  • Those who do not use pacemakers.
  • Those who do not take hormone substitutes.
  • Those who agree to participate in the research.

Exclusion criteria

  • Those who are pregnant.

Treatment and study plan

Low-intensity TMS

Device

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 mT and frequency of 50 Hz in theta bursts.

Transcranial Magnetic Stimulation Sham

Device

The control group will receive the simulation of low-intensity TMS without magnetic field induction.

Primary outcomes

  1. Improvement in symptoms of depression

    Time frame: From admission until the end of the 4 days of intervention and one month after the end of the intervention

    Improvement in depression symptoms, assessed by the Hamilton Depression Rating Scale (HAM-D17) which measures the severity of depression symptoms.

Secondary outcomes

  1. Changes in serum concentrations of 5-HIAA and BDNF

    Time frame: From admission until the end of the 4 days of intervention.

    5-HIAA and BDNF are neurochemical biomarkers that may correlate with response to depression treatment.

Other outcomes

  1. Subjective changes in patient health

    Time frame: From admission until the end of the 4 days of intervention and one month after the end of the intervention

    Evaluates the perception of patients' depressive symptoms using a self-assessment scale, complementing the primary measure

  2. Changes in sleep quality

    Time frame: From admission and one month after the end of the intervention

    It assesses sleep quality and detects possible improvements in sleep as an additional effect of low-intensity TMS, its improvement may indicate a secondary benefit of the treatment.

  3. Changes in physical activity level

    Time frame: From admission until the end of the 4 days of intervention and one month after the end of the intervention

    The International Physical Activity Questionnaire provides information about changes during the intervention week in the patient's physical activity intensity.

  4. Changes in the Clinical Global Impression Scale (CGI)

    Time frame: From admission until the end of the 4 days of intervention.

    CGI will help measure clinical changes globally.

Study contacts

Contact information is provided by the study sponsor or research team.

Ma. Eugenia Garay Sevilla, Medical Sciences PhD

CONTACT

[email protected]

+524731414191

Olga E Escobar Florez, Master of Medical Sciences

CONTACT

[email protected]

+524773703795

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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