South Korea enters clinical trials for digital device to treat depression

South Korea's Ministry of Science, Technology, and Information Communications announced on the 10th that a confirmatory clinical trial of the ``digital depression treatment device'' that the ministry is supporting the development of will begin on the 19th of this month.
Through a research and development project called ``Development of non-face-to-face affective disorder prevention and management platform technology in the post-corona era,'' the ministry is
We support the development of digital mental health services (wellness services) and digital treatment devices that can prevent, manage, and treat mental health problems such as stress and stress. Kim Hyo from Hanyang University
A research team led by Professor Nsuk is in charge of this research and is developing four types of digital treatment devices for depression, anxiety, obsessive thoughts, etc.
Among them, a digital depression treatment device received confirmation clinical approval from the Ministry of Food and Drug Safety in February this year.
The test plan has been approved and confirmatory clinical trials will begin on the 19th of this month. In the private sector, there are cases in which digital therapy devices have been approved for the treatment of insomnia and anxiety disorders, but digital therapy devices for the purpose of treating depression have not yet been approved.
This is the first time that a device has entered confirmatory clinical trials with the support of a national research and development project. This device is a software-based, personalized, digital therapeutic device with no confirmatory clinical trials.
The event will be held at Samsung Seoul Hospital and Hanyang University Hospital, which are participating in the research project. From the beginning of the research project, the research team collaborated with the Digital Health Regulatory Support Division of the Ministry of Food and Drug Safety and
In order to quickly commercialize digital treatment devices, we have discussed sharing the current state of research and providing support regarding licensing procedures. The plan is to complete the clinical trials and apply for product approval by the middle of next year, and there are concerns.
The company also plans to continue developing digital treatment devices for things like obsessions. Meanwhile, the research team is developing a service that allows people to test and manage their own mental health using mobile phone apps.
, has been available to national army soldiers since September of this year. Any member of the Armed Forces can freely use it through the National Love Portal site regardless of location or time. As of the end of November, there were a cumulative total of 2,173 military personnel.
Soldiers are joining. The number of subscribers and the number of times content has been used have been steadily increasing since the service began. Noh Kyung-won, director of the ministry's research and development policy office, said, ``The public's mental health prevention and
While recovery remains a key national agenda item, digital technology can play a major role in mental health prevention and management by making mental health care more convenient for citizens.
"We hope that the confirmatory clinical trials of digital therapeutic devices will be conducted smoothly, and that the excellent results supported through the national R&D project will be able to quickly enter the market."
said. Kang Yong-gyu, director of the Digital Health Regulatory Support Division of the Ministry of Food and Drug Safety, said, ``The Ministry of Food and Drug Safety will preemptively provide evaluation standards for digital treatment devices to improve depression, and the research team will
We have been actively supporting the rapid entry of this product into clinical trials through regular meetings with the government.''
We would like to actively support the rapid commercialization of medical devices."