Clinical trial NCT06667180: Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
Official title: Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Depression - Major Depressive Disorder
Transcranial Magnetic Stimulation
Placebo
Keywords: accelerated low-intensity transcranial magnetic stimulation
Major depressive disorder
depression
brain-derived neurotrophic factor
5-hydroxyindoleacetic acid
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Improvement in symptoms of depression
timeFrame: From admission until the end of the 4 days of intervention and one month after the end of the intervention
Secondary outcomes:
measure: Changes in serum concentrations of 5-HIAA and BDNF
timeFrame: From admission until the end of the 4 days of intervention.
Other outcomes:
measure: Subjective changes in patient health
timeFrame: From admission until the end of the 4 days of intervention and one month after the end of the intervention
measure: Changes in sleep quality
timeFrame: From admission and one month after the end of the intervention
measure: Changes in physical activity level
timeFrame: From admission until the end of the 4 days of intervention and one month after the end of the intervention
measure: Changes in the Clinical Global Impression Scale (CGI)
timeFrame: From admission until the end of the 4 days of intervention.
Locations:
city: León
country: Mexico
facility: High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Ma. Eugenia Garay Sevilla, PhD in medical sciences
role: STUDY_DIRECTOR
affiliation: Universidad de Guanajuato
name: José M De la Roca Chiapas, PhD in medical sciences
role: STUDY_DIRECTOR
affiliation: Universidad de Guanajuato
name: Blanca O Murillo Ortíz, PhD in medical sciences
role: STUDY_DIRECTOR
affiliation: Universidad de Guanajuato
name: Angélica Hernández Rayas, Physics PhD
role: STUDY_CHAIR
affiliation: Universidad de Guanajuato
name: Olga E Escobar Florez, Master of Medical Sciences
role: PRINCIPAL_INVESTIGATOR
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