Depression - Major Depressive Disorder, Placebo, Transcranial Magnetic Stimulation
Conditions
Keywords
accelerated low-intensity transcranial magnetic stimulation, Major depressive disorder, depression, brain-derived neurotrophic factor, 5-hydroxyindoleacetic acid
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.
Interventions
DEVICELow-intensity TMS
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.
DEVICETranscranial Magnetic Stimulation Sham
The control group will receive the simulation of low-intensity TMS without magnetic field induction.
Sponsors
Instituto Mexicano del Seguro Social
Universidad de Guanajuato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in symptoms of depression | From admission until the end of the 4 days of intervention and one month after the end of the intervention | Improvement in depression symptoms, assessed by the Hamilton Depression Rating Scale (HAM-D17) which measures the severity of depression symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum concentrations of 5-HIAA and BDNF | From admission until the end of the 4 days of intervention. | 5-HIAA and BDNF are neurochemical biomarkers that may correlate with response to depression treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective changes in patient health | From admission until the end of the 4 days of intervention and one month after the end of the intervention | Evaluates the perception of patients' depressive symptoms using a self-assessment scale, complementing the primary measure |
| Changes in sleep quality | From admission and one month after the end of the intervention | 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 | From admission until the end of the 4 days of intervention and one month after the end of the intervention | 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) | From admission until the end of the 4 days of intervention. | CGI will help measure clinical changes globally. |
Countries
Mexico
Contacts
Primary ContactOlga E Escobar Florez, Master of Medical Sciences
Backup ContactMa. Eugenia Garay Sevilla, Medical Sciences PhD
Outcome results
None listed