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Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients

Depression Clinical Trial

Official title:
A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression

Clinical Trial Summary

This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

Clinical Trial Description

During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04709952
Study type Interventional
Source Samsung Medical Center
Contact Ji-Hyun Baek
Phone +82 2-2008-4388
Email jh1.baek@samsung.com
Status Recruiting
Phase N/A
Start date January 28, 2021
Completion date June 30, 2023
View Details
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