Depression

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

Recruiting · León, Guanajuato

✓ PHASE1, PHASE2

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•You are between 18 and 60 years old.
•You have a diagnosis of major depressive disorder (MDD) made by your treating psychiatrist.
•You keep taking your current treatment and come to follow-up visits at the health facility.
•You do not have a history of epilepsy, schizophrenia, or neurosurgery.
•You do not have metal plates in your skull, neck, chest, or shoulder, and you do not use a pacemaker.

🚫 You may not be able to join if…

•You are pregnant.
•You have a history of epilepsy.
•You have a history of schizophrenia.
•You have had neurosurgery.
•You have metal plates in your skull, neck, chest, or shoulder, or you use a pacemaker.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18–60
✓Have Depression

!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT06667180 · Locations: Guanajuato