Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients
A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression
1 other identifier
interventional
141
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Jan 2021
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedSeptember 23, 2021
September 1, 2021
2.2 years
January 12, 2021
September 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Working memory ability evaluation(N-Back tast)
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.
Change from Baseline Working memory ability evaluation at 6 weeks.
Secondary Outcomes (2)
Hamilton Rating Scale
Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Hamilton Anxiety Rating Scale
Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks
Study Arms (3)
High real stimulation group
ACTIVE COMPARATOR2mA tDCS stimulation daily (42 times) for 6 weeks
Low real stimulation group
ACTIVE COMPARATOR1mA tDCS stimulation daily (42 times) for 6 weeks
Sham stimulation group
SHAM COMPARATORsham stimulation daily (42 times) for 6 weeks
Interventions
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Lee CW, Park K, Ahn JE, Jang Y, Park YS, Yu H, Lee D, Ihm HK, Lee J, Kim J, Lee YI, Lim SE, Kwon SS, Park HY, Ha TH, Yoon IY, Myung W, Baek JH. Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial. Eur Psychiatry. 2025 Jan 15;68(1):e15. doi: 10.1192/j.eurpsy.2024.1811.
PMID: 39809704DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji-Hyun Baek
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 14, 2021
Study Start
January 28, 2021
Primary Completion
March 31, 2023
Study Completion
June 30, 2023
Last Updated
September 23, 2021
Record last verified: 2021-09