First digital treatment against depression approved in the US

Rejoyn, the first digital prescription treatment against major depressive disorder, received the green light from the United States Food and Drug Administration; however, some experts remain skeptical about this initiative.

 
A press release from the FDA states that the innovation by the companies Otsuka Pharmaceutical and Click Therapeutics, is an application for smartphones which is used together with antidepressants in people over 22 years of age.

In view of this step, an article by CNN in Spanish noted that Dr. John Torous, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, who was not involved in the development of Rejoyn, pointed out that this cognitive-emotional training approach does not yet represent a well-established mechanism and the research is still exploratory.

However, the FDA report indicated that its clearance was based on the results of a clinical trial in which 386 people aged 22 to 64 with a diagnosis of major depressive disorder, who did not respond to antidepressants, were assigned to use the app or similar apps with memory tasks that did not involve cognitive-emotional training or cognitive-behavioral therapy.

“Although participants using the Rejoyn app showed an improvement in depressive symptoms from baseline, the mean change was not significantly different from the change observed with the simulated app; but the trial recorded no side effects,” the regulatory institution noted.