Ybrain Recruiting Patients for Real-World Clinical Trial of Electronic Medicine for Depression

Ybrain's transcranial direct current stimulation (tDCS)-based home-use electronic medicine for depression, 'MindSteam' [Photo by Ybrain]

Electronic medicine platform company Ybrain announced on the 28th that it has begun recruiting patients to participate in the real-world clinical trial of the electronic medicine for depression, 'Mindsteem.' This clinical trial is being conducted as part of a research project on the development of electronic medicine technology under the 2022 first phase of the Health and Medical Technology R&D Project selected by the Ministry of Health and Welfare last year.

Through this clinical trial, Ybrain aims to secure real-world data (RWD) of Mindsteem, which became the world's first home-use electronic medicine for depression approved by the Korean Ministry of Food and Drug Safety in 2021, and to derive technological evidence based on this data. This will also lay the foundation for future new medical technology assessments and reimbursement. Mindsteem previously demonstrated a remission rate of 62.8% for depressive symptoms when applied alone for 30 minutes daily over six weeks in a multicenter clinical trial conducted at six university hospitals in Korea in 2020. This is explained as a higher symptom improvement effect compared to the remission rate of existing antidepressants (about 50%).

The 'Clinical Field Verification Study of Transcranial Direct Current Stimulation (tDCS) for Patients with Depression' involves a total of five hospitals: Yongin Severance Hospital, Hallym University Chuncheon Sacred Heart Hospital, International St. Mary's Hospital, National Health Insurance Ilsan Hospital, and Myongji Hospital. The total number of patients to be recruited is 198, targeting patients receiving treatment for depression at hospitals. Once patient recruitment is complete, Mindsteem will be prescribed at the hospitals, and home treatment will be conducted through self-application at the patients' homes for a total of six weeks.

Detailed information on how to participate in the clinical trial can be found in the recruitment announcement on Ybrain's official website. The application period will close once 198 patients have been recruited.

Lee Gi-won, CEO of Ybrain, said, "This clinical trial will greatly contribute to the advancement of Mindsteem's personalized treatment technology," and added, "We hope that many patients with depression who have fears about antidepressant drugs or interest in new treatments will participate in this clinical trial."