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

June 2, 2021 updated by: DANIEL SAN JUAN ORTA, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Ciudad De México
      • Mexico City, Ciudad De México, Mexico, 14269
        • Recruiting
        • Instituto Nacional de Neurologia y Neurocirugia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel San-Juan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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).
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Children Depression Inventory score from the beginning to the end of the study
Time Frame: 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
At the beginning of the study and at the end of weeks 2, 4, 8, and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study
Time Frame: 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.
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
Time Frame: 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.
At the beginning of the study and at the end of weeks 2, 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Collaborators

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Personal data information will remain with strictly confidential character in the research center. However, personal data will be examined by all individuals related to the research project and/or those selected for its analysis, including representatives of Mexican health authorities and other regulatory agencies with inspection purposes.

If the data obtained through this study is published, the report will be written in a way no person could identify their personal data or identity, unless such information is officially required by any mexican or foreign authority.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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