Table 4.
Digital therapeutics in child and adolescent psychiatry approved clinical trials from MFDS*
| Device | Applicant | Target disease | Clinical trial phase | MFDS approval |
|---|---|---|---|---|
| Minds.NAVI | MINDsAI | MDD | Pivotal study | November 3, 2021 |
| CHEEU.Forest | MINDsAI | MDD | Pivotal study | December 23, 2021 |
| Anxeilax | HAII | GAD | Confirmatory clinical study | December 30, 2021 |
| D-kit/EF1 | DoBrain | Mild intellectual disorder, borderline intellectual functioning | Pivotal study | October 20, 2022 |
| ALCO-THERA | Medimind | Alcohol abuse | Confirmatory clinical study | October 20, 2022 |
| OMNFIT DTx MDD | Omni C&S | MDD | Confirmatory clinical study | November 29, 2022 |
| Neuro-World | WOORI SOFT | ADHD | Pivotal study | December 1, 2022 |
| AttnKare-D | Hippo T&C | ADHD | Confirmatory clinical study | January 6, 2023 |
| No official name (CBT-based) | WELT | Eating disorder | Confirmatory clinical study | January 17, 2023 |
| NDTx-01 | Neudive | ASD or SCD | Pivotal study | February 22, 2023 |
| No official name (metaverse-based) | DoBrain | High-functioning ASD | Pivotal study | March 23, 2023 |
| NICO-THERA | Medimind | Nicotin abuse | Confirmatory clinical study | April 10, 2023 |
| BlueKare-T | Hippo T&C | Depression | Confirmatory clinical study | June 8, 2023 |
*these cases are referenced from data retrieved between 2021 Sep 1 and 2023 Jul 7 from MFDS [58]. ADHD, attention deficit hyperactivity disorder; ASD, autism spectrum disorder; CBT, cognitive behavioral therapy; GAD, generalized anxiety disorder; MDD, major depressive disorder; MFDS, Ministry of Food and Drug Safety of Republic of Korea; SCD, social communication disorder