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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA). Anodal stimulation will be applied on F3 according to the intentional 10/20 system, and the cathode will be applied on the contra lateral position (F4).
Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS). Placebo will be administered using the same stimulation parameters and the active treatment position of the electrodes, but current wil be aborted 30 seconds after the ascending slope has begun.
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, Mexico
RECRUITINGChange of Children Depression Inventory score from the beginning to the end of the study
It is one of the most widely used self-applied scales to assess depressive symptoms in children and teenagers. The scale consists of 27 items, each item with 3 response options, where 0= absence of symptoms, 1= moderate symptoms, and 2= severe symptoms. The total score ranges from 0-54. The scale manual contains the psychometric properties reported by the author. It is recommended for use in children from 7-17 years old. a SCORE OF 20 was established as a cut-off point for indicating depression problems
Time frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study
The C-SSRS is a semi-structured interview which collects the onset, severity and frequency of behavior and thoughts related to suicide during the assessement period. Therefore, 4 constructs are measured.
Time frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
Change of Young Mania Rating Scale score from the begining to the end of the study
It is an instrument for quantifying mania symptoms that consist of 11 items, each one with 5 response options, which reflect higher score if great intensity. It is applied by the clinician and is based on the subjective report of the patient during 48 hrs prior to the evaluation, as well as on the observation of the patient's behavior during the interview. The patient selects the intensity level of the symptom for each item with an option from 0 to 4. The total range of the scale from 0-60 points where higher scores indicate a greater degree of manic characteristics; the minimum score to define new-onset mania or hypomania is 8 points at the end of the weeks 2, 4, 8 and 12 to assess mania or hypomania during the clinical trial.
Time frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12
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Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.