FDA clears first digital treatment for depression, but experts caution that research is still early

Rejoyn, made by Otsuka Pharmaceutical and Click Therapeutics, is a smartphone app intended for use alongside antidepressant medications for people 22 and older who have a diagnosis of major depressive disorder. It employs a six-week program that combines a new approach called cognitive-emotional training and cognitive behavioral therapy lessons, according to a news release.

John Torous, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, who was not involved in the development of Rejoyn, said that this cognitive-emotional training approach is not a well-established mechanism and that the research is still exploratory. The FDA clearance for Rejoyn was granted based on results from a clinical trial involving 386 people ages 22 to 64 who had a diagnosis of major depressive disorder that was not responsive to antidepressants.

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