Status:
UNKNOWN
Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients
Lead Sponsor:
ji hyun baek, MD, Ph.D
Conditions:
Depression
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief 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 stimulati...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder
- CGI severity (severity of Illness) score of 3 or higher
- Patients receiving medication for depression at the time of study participation
- Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires
Exclusion
- History of clinically significant medical neurological disease or history of head injury
- In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
- Severe suicidal risk or psychotic symptoms determined by the clinician
- In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
- Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
- Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial
- Pregnant women
- Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04709952
Start Date
January 28 2021
End Date
June 30 2023
Last Update
September 23 2021
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Samsung Medical Center
Seoul, South Korea