Rejoyn is a prescription-only digital therapeutic smartphone app, it has been approved by the US FDA for the treatment of Major Depressive Disorder (MDD) in adults ages 22 and up.[1] It is to be used in conjunction with a standard antidepressant medication, and with professional guidance and support.[2]
Rejoyn was developed by Otsuka America Pharmaceutical Inc., and gained FDA approval as a "medical device" on March 30th, 2024.[3] The smartphone app helps patients with depression using exercises based on cognitive behavioral therapy (CBT), along with timed notifications to keep the patient engaged and in treatment. Randomized controlled trials showed that the Rejoyn app was more effective at relieving depression symptoms compared to a "sham app", a placebo app that required similar effort but was not intended to be helpful. Dr. John Torous, MD, MBI,[a] a psychiatrist at the Beth Israel Deaconess Medical Center in Boston, said that the app seems to pose minimal risks, and is an important step forward in unlocking the power of smartphones in treating psychiatric disorders.[4]
Notes
- a1 MBI for Masters of Biomedical Informatics.
References
- ^ Cheng, Mira (2024-04-02). "FDA clears first digital treatment for depression, but experts caution that research is still early". CNN. Retrieved 2024-04-04.
- ^ FDA Newsroom (2024-04-02). "FDA Roundup: April 2nd, 2024". FDA Press Releases. US Food and Drug Administration. Retrieved 4 April 2024.
- ^ "FDA 510k Approval Notice for Rejoyn". FDA.gov. US FDA. 2024-03-30. Retrieved 4 April 2024.
- ^ Fadel, Leila (2024-04-04). "The FDA has approved the first app to help treat depression". NPR Morning Edition. NPR. Retrieved 4 April 2024.
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This page was last edited on 13 May 2024, at 14:16