Clinical trial NCT04780152: TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic
Official title: Assessment of Efficacy and Safety of Anodal Transcranial Direct Current Stimulation (TDCS) in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: TDCS
Pediatrics
COVID-19
Adolescents
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor class: OTHER
Collaborators: name: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
First posted: 2021-03-03
Enrollment: 172
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentric, randomized, clinical trial, phase 2/3 of superiority, with two parallel arms, comparative, controlled with placebo, in which changes in a major depressive disorder scale will be assessed (change in CDI score measured at week 10 compared with initial score) comparing with basal score and between the two groups (\>40% measured at 2 weeks, 1,2, 3 months of treatment).
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Change of Children Depression Inventory score from the beginning to the end of the study
timeFrame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
Secondary outcomes:
measure: Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study
timeFrame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
measure: Change of Young Mania Rating Scale score from the begining to the end of the study
timeFrame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía
state: Ciudad De México
Study officials:
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