tdcs in pediatric and teenage patients with major depressive disorder during covid-19 pandemic

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to assess safety and efficacy of nodal transcranial direct current stimulation in pediatric and teenager population with major depressive disorder in the covid-19 pandemic.

after being widely informed about the study and potential risks, all the patients giving voluntary informed consent will be randomized in a 1:1 ratio to a tdcs group (a-tdcs+ standard treatment) or control group (placebo-simulations a-tdcs+ standard treatment).

Eligibility criteria:
inclusion criteria: * major depressive disorder (mdd) diagnosed through the clinical interview based on the affective disorders and schizophrenia agenda for schoolchildren-current version and for life k- sads-pl for its acronym in english, with a single or recurrent episode lasting ≥4 weeks. * the current depressive episode must have a duration of less than 5 years and be at least greater than 2 months in which the patient meets the operational definition of mdd from the dsm-v. * cid scale with values equal to 17 or higher in the clinical evaluation. * no use of another medication during the intervention days. * they should not be taking antidepressants at the beginning of the study (last 4 weeks) or it must have passed the adequate time of "washing"/ clearance of antidepressant drugs established as 5 or more biological half-lifes or 5 days before the randomization. * to be able and willing to give their informed consent, both, the parent or tutor and the participant who is between the ages of 14-17 years. in the age group of 10-13 years the assent of the patient and the consent of the parent or tutor. * use of benzodiazepines (eg lorazepam) equivalent to 20 mg of diazepam and which remains stable during the study. * patients with an unchanged drug treatment for mdd in the last 4 weeks and who agree to switch the fluoxetine at the time of randomization, meeting the previously described antidepressant criteria. exclusion criteria: * previous skull surgery. * recent skull injury (6 months). * use of central nervous system stimulants. * respiratory system infections. * does not sign or is unable to sign informed consent or legal tutors/parents do not consent. * clinical condition or anomaly, which in the researcher's opinion, compromises patient´s safety or data quality. * uncontrolled co-existent medical condition, progressive cerebral disorder, severe systemic diseases, symptomatic disease, cardiac disease, skin chronic diseases or damaged scalp which could interfere with tdcs stimulation. * any skull metal implant (excluding dental filling or titanium plates) or medical devices (cardiac pacemaker, deep cerebral stimulator, drug infusion pump, cochlear implant, vagus nerve stimulator). * direct researcher relatives or personnel directly involved in the study. * acute suicide risk measured through the montgomery asberg depression rating scale (madrs) \>4 points or positivity of the 4th or 5th item of the columbia suicide severity rating scale (c-ssrs). * depression resistant to treatment with \>4 well indicated drugs during the current episode. * bipolar disorder history or current mania symptoms. * treatment with electroshock therapy concomitantly and during the last 12 months. * other relevant psychiatric disorders according to the dsm 5 (except generalized anxiety disorder, specific phobia or separation anxiety disorder). * previous treatment with tdcs for a different disease to the major depressive disorder. * intellectual development disorder previously documented or clinical evaluation fulfilling the cie-f79 criteria. * due to the fact that treatment with tdcs has counter-indications, will be excluded: those with history of non provoked seizures, convulsive disorders, history of febrile seizure, family history of epilepsy or brain tumor, pregnancy. * counter-indication or history of adverse reactions from mild to severe to fluoxetine. elimination criteria: * patients that do not complete the neuropsychological assessment tests. * interruption of the intervention of less than 50% of what was scheduled. * onset of active suicidal ideation. * active psychosis. * start of emerging mania treatment. * pregnancy.

Keywords: tdcs pediatrics covid-19 adolescents