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

NCT04780152 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2021-06-04

No results posted yet for this study

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.

Conditions

Interventions

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).

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.

Sponsors & Collaborators

  • Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

    collaborator OTHER_GOV

  • El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-08-31
Completion
2022-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780152 on ClinicalTrials.gov