TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic

This is an interventional treatment trial for Major Depressive Disorder focused on measuring TDCS, Pediatrics, COVID-19, Adolescents Read More

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.