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

Phase 1

Recruiting

• Conditions: Depression - Major Depressive Disorder; Transcranial Magnetic Stimulation; Placebo

• Registration Number: NCT06667180
• Lead Sponsor: Universidad de Guanajuato

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-28
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-01-28
• Study Completion: 2025-05-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• Those who are pregnant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in symptoms of depression	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 Outcome Measures

Name	Time	Method
Changes in serum concentrations of 5-HIAA and BDNF	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.

Trial Locations

Locations (1)

High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute; 🇲🇽 León, Guanajuato, Mexico