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

NCT06667180 | Recruiting Phase 1 DMC

• 2 other identifiers: CEPIUG-P35-2023R-2024-785-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Depression - Major Depressive Disorder; Transcranial Magnetic Stimulation; Placebo

Keywords

accelerated low-intensity transcranial magnetic stimulation; Major depressive disorder; depression; brain-derived neurotrophic factor; 5-hydroxyindoleacetic acid

Outcome Measures

Primary Outcomes (1)

• Improvement in symptoms of depression

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

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

Secondary Outcomes (1)

• Changes in serum concentrations of 5-HIAA and BDNF

  From admission until the end of the 4 days of intervention.

Other Outcomes (4)

• Subjective changes in patient health

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

• Changes in sleep quality

  From admission and one month after the end of the intervention

• Changes in physical activity level

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

Study Arms (2)

Low-intensity TMS

EXPERIMENTAL

This group will receive the real low-intensity TMS

Device: Low-intensity TMS

Sham low-intensity TMS

PLACEBO COMPARATOR

This group will receive the simulation of the low-intensity TMS

Device: Transcranial Magnetic Stimulation Sham

Interventions

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.

Low-intensity TMS

Transcranial Magnetic Stimulation Sham DEVICE

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

Sham low-intensity TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Those who are pregnant.

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

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

León, Guanajuato, 37328, Mexico

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Ma. Eugenia Garay Sevilla, PhD in medical sciences

  Universidad de Guanajuato

  STUDY DIRECTOR

• José M De la Roca Chiapas, PhD in medical sciences

  Universidad de Guanajuato

  STUDY DIRECTOR

• Blanca O Murillo Ortíz, PhD in medical sciences

  Universidad de Guanajuato

  STUDY DIRECTOR

• Angélica Hernández Rayas, Physics PhD

  Universidad de Guanajuato

  STUDY CHAIR

• Olga E Escobar Florez, Master of Medical Sciences

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga E Escobar Florez, Master of Medical Sciences

CONTACT

+524773703795; oe.escobarflorez@ugto.mx

Ma. Eugenia Garay Sevilla, Medical Sciences PhD

CONTACT

+524731414191; marugaray_2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: October 28, 2024
• Primary Completion: May 30, 2025
• Study Completion: August 26, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)