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

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (Other)

Overall Status

Recruiting

CT.gov ID

NCT04780152

Collaborator

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico (Other)

172

Enrollment

Location

Arms

Anticipated Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Transcranial Direct Current Stimulation Device: Placebo-simulation of transcranial direct current stimulation Drug: Fluoxetine Tablets	Phase 2/Phase 3

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

In addition some of the personnel (evaluators, data analyst, result analyst) will be blinded in order to increase the internal validity of our study. A blind person is considered by the person that apply the intervention.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS arm Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).	Device: Transcranial Direct Current Stimulation 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). Other Names: TDCS Anodal electric transcranial direct current stimulation Drug: Fluoxetine Tablets Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily. Other Names: Antidepressants
Placebo Comparator: Control arm Participant receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).	Device: Placebo-simulation of transcranial direct current stimulation 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. Drug: Fluoxetine Tablets Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily. Other Names: Antidepressants

Arm

Intervention/Treatment

Experimental: tDCS arm

Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).

Device: Transcranial Direct Current Stimulation

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).

Other Names:

TDCS

Anodal electric transcranial direct current stimulation

Drug: Fluoxetine Tablets

Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.

Other Names:

Antidepressants

Placebo Comparator: Control arm

Participant receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).

Device: Placebo-simulation of transcranial direct current stimulation

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.

Drug: Fluoxetine Tablets

Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.

Other Names:

Antidepressants

Outcome Measures

Primary Outcome Measures

Change of Children Depression Inventory score from the beginning to the end of the study [At the beginning of the study and at the end of weeks 2, 4, 8, and 12]
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

Secondary Outcome Measures

Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study [At the beginning of the study and at the end of weeks 2, 4, 8, and 12]
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.
Change of Young Mania Rating Scale score from the begining to the end of the study [At the beginning of the study and at the end of weeks 2, 4, 8, and 12]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.