Who is eligible for clinical trial NCT06667180?

Participants must meet the protocol's inclusion criteria for Depression - Major Depressive Disorder. The stated age range is 18 Years to 60 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06667180 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-05-05

Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels (NCT06667180)

🟢 Recruiting Phase1 / Phase2 ⚙️ Medical Device Protocol Sponsor: Universidad de Guanajuato

🩺 Plain-English Summary (8th-Grade Level)

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 can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (2 items).

Location: High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute — León, Guanajuato

Age range: 18 Years to 60 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Those who are pregnant.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

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

📞 Contact the Study Coordinator

Phone: +524773703795

Email: oe.escobarflorez@ugto.mx

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Enhancing Slow Wave Sleep in Depression — Winston-Salem, North Carolina
Digital Intervention for Physical Activity — Auburn, Alabama
Sham-Controlled Rapid-Acting Neuromodulation for Depression — Sacramento, California

Explore by condition: All Depression - Major Depressive Disorder clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗