NCT06667180 Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
| NCT ID | NCT06667180 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Universidad de Guanajuato |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-10-28 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. Exclusion Criteria: * Those who are pregnant.
Contact & Investigator
Ma. Eugenia Garay Sevilla, PhD in medical sciences
STUDY DIRECTOR
Universidad de Guanajuato
Frequently Asked Questions
Who can join the NCT06667180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06667180 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06667180 currently recruiting?
Yes, NCT06667180 is actively recruiting participants. Contact the research team at oe.escobarflorez@ugto.mx for enrollment information.
Where is the NCT06667180 trial being conducted?
This trial is being conducted at León, Mexico.
Who is sponsoring the NCT06667180 clinical trial?
NCT06667180 is sponsored by Universidad de Guanajuato. The principal investigator is Ma. Eugenia Garay Sevilla, PhD in medical sciences at Universidad de Guanajuato. The trial plans to enroll 40 participants.
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