Status:
COMPLETED
The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
Lead Sponsor:
Ybrain Inc.
Collaborating Sponsors:
The Catholic University of Korea
Inje University
Conditions:
Depression
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
Detailed Description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\~7 times a week and they wer...
Eligibility Criteria
Inclusion
- Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
- Patients with a K-BDI-II score of 14 or more and 28 or less
- In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.
Exclusion
- Patients diagnosed with Axis I disorders other than major depressive disorder
- Patients diagnosed with other depressive disorders besides major depressive disorder
- Patients who have attempted suicide within 6 months of screening
- Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
- Patients judged to have other reasons for prohibition of use of tDCS medical devices
- Patients currently taking antidepressants
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04720040
Start Date
December 23 2019
End Date
October 15 2020
Last Update
January 22 2021
Active Locations (1)
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1
YBrain Inc.
Seongnam-si, Gyeonggi-do, South Korea, 13449