What is low-intensity transcranial magnetic stimulation studying for major depressive disorder?

Low-intensity transcranial magnetic stimulation (TMS) is being studied to see if it can reduce symptoms of major depressive disorder (MDD) and affect certain blood markers like 5-HIAA and BDNF. This trial aims to understand how TMS impacts mood and brain chemistry, with the Universidad de Guanajuato leading the research.

Who may be eligible for this major depressive disorder clinical trial?

Adults aged 18 to 60 years with a diagnosis of major depressive disorder may be eligible. Both men and women can participate if they have no history of epilepsy, schizophrenia, neurosurgery, or certain medical devices like pacemakers. Please review eligibility criteria for more details.

Is there any cost to participate in this major depressive disorder clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 60Years

All Genders

ID06667180

Study of Low-intensity Transcranial Magnetic Stimulation to Treat Major Depressive Disorder and Its Effects on Serotonin and Brain Growth Factors

Led by Universidad de Guanajuato · Updated on 2025-05-08

Participants Needed

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of low-intensity transcranial magnetic stimulation TMS on major depressive disorder MDD, along with its impact on levels of 5-hydroxyindoleacetic acid 5-HIAA and brain-derived neurotrophic factor BDNF. This randomized clinical trial aims to determine whether low-intensity TMS can reduce depressive symptoms and cause significant changes in these blood markers. The safety of TMS will also be assessed by monitoring symptoms during and after the treatment period. Participants will be randomly assigned to receive either real low-intensity TMS or a sham simulated TMS. The real TMS treatment involves 4 days of therapy with 5 daily sessions lasting 200 seconds each, spaced by 10-minute breaks. The magnetic field intensity used ranges from 2 to 4 milliTesla, delivered at 50 Hz in theta bursts. The sham group receives simulated treatment without magnetic field induction. During the study, participants will undergo an initial clinical assessment and provide a 5 mL blood sample before treatment. Symptoms will be monitored daily throughout the 4-day intervention. At the end, another blood sample will be collected and clinical assessments repeated. Safety monitoring will continue for one month after treatment to observe any adverse effects. The total participation includes the 4-day intervention and the follow-up period for symptom evaluation.

CONDITIONS

Brief 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

Age: 18Years - 60Years

All Genders

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 treatment and attending follow-up consultations at the health facility
No history of epilepsy, schizophrenia, or neurosurgeries
No metal plates in the skull, neck, chest, or shoulder
No use of pacemakers
No use of hormone substitutes
Agreement to participate in the research

You will not qualify if you...

Pregnant individuals

Research Team

Olga E Escobar Florez, Master of Medical Sciences

Ma. Eugenia Garay Sevilla, Medical Sciences PhD

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