Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Pregnancy
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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
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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