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| ID | Type | Description | Link |
|---|---|---|---|
| R-2024-785-001 | Registry Identifier | National Committee for Scientific Research |
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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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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:
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-intensity TMS | Experimental | This group will receive the real low-intensity TMS |
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| Sham low-intensity TMS | Placebo Comparator | This group will receive the simulation of the low-intensity TMS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-intensity TMS | Device | 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 mT and frequency of 50 Hz in theta bursts. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From admission until the end of the 4 days of intervention and one month after the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum concentrations of 5-HIAA and BDNF | 5-HIAA and BDNF are neurochemical biomarkers that may correlate with response to depression treatment. | From admission until the end of the 4 days of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective changes in patient health | Evaluates the perception of patients' depressive symptoms using a self-assessment scale, complementing the primary measure | From admission until the end of the 4 days of intervention and one month after the end of the intervention |
| Changes in sleep quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga E Escobar Florez, Master of Medical Sciences | Contact | +524773703795 | oe.escobarflorez@ugto.mx | |
| Ma. Eugenia Garay Sevilla, Medical Sciences PhD | Contact | +524731414191 | marugaray_2000@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ma. Eugenia Garay Sevilla, PhD in medical sciences | Universidad de Guanajuato | Study Director |
| José M De la Roca Chiapas, PhD in medical sciences | Universidad de Guanajuato | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute | Recruiting | León | Guanajuato | 37328 | Mexico |
Individual Participant Data (IPD) information will not be shared to ensure the privacy and confidentiality of participants, sharing IPD could expose participants to additional risks of identification, for these reasons, and to protect the rights and confidentiality of participants, we have decided not to share IPD in this study.
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| Transcranial Magnetic Stimulation Sham | Device | The control group will receive the simulation of low-intensity TMS without magnetic field induction. |
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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. |
| From admission and one month after the end of the intervention |
| 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. | From admission until the end of the 4 days of intervention and one month after the end of the intervention |
| Changes in the Clinical Global Impression Scale (CGI) | CGI will help measure clinical changes globally. | From admission until the end of the 4 days of intervention. |
| Blanca O Murillo Ortíz, PhD in medical sciences | Universidad de Guanajuato | Study Director |
| Angélica Hernández Rayas, Physics PhD | Universidad de Guanajuato | Study Chair |
| Olga E Escobar Florez, Master of Medical Sciences | Universidad de Guanajuato | Principal Investigator |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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