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.
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 are pregnant.
Parallel
Low-intensity TMS
DeviceLow-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 mT and frequency of 50 Hz in theta bursts.
Transcranial Magnetic Stimulation Sham
DeviceThe control group will receive the simulation of low-intensity TMS without magnetic field induction.
Improvement in symptoms of depression
Improvement in depression symptoms, assessed by the Hamilton Depression Rating Scale (HAM-D17) which measures the severity of depression symptoms.
Changes in serum concentrations of 5-HIAA and BDNF
5-HIAA and BDNF are neurochemical biomarkers that may correlate with response to depression treatment.
Subjective changes in patient health
Evaluates the perception of patients' depressive symptoms using a self-assessment scale, complementing the primary measure
Changes in sleep quality
It assesses sleep quality and detects possible improvements in sleep as an additional effect of low-intensity TMS, its improvement may indicate a secondary benefit of the treatment.
Changes in physical activity level
The International Physical Activity Questionnaire provides information about changes during the intervention week in the patient's physical activity intensity.
Changes in the Clinical Global Impression Scale (CGI)
CGI will help measure clinical changes globally.
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Universidad de Guanajuato
Lead sponsor
Instituto Mexicano del Seguro Social
Collaborator
