NCT04780152

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2021-03-03
• Last updated: 2021-06-04

Locations

1 site across 1 country: Mexico