NCT02657980

The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Ybrain Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Detailed description

Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Yband(YDT-201N)	transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
DEVICE	Sham-Yband(YDT-201N)	transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-01-18
• Last updated: 2017-01-26

Locations

1 site across 1 country: South Korea