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This is a first: the American Food and Drug Administration (FDA) authorizes the use of a digital treatment, by prescription, against depression. It is a smartphone application, called Rejoyn.
For the first time, the American Food and Drug Administration, responsible for monitoring food and drug products, authorizes the use of digital prescription treatment to combat major depressive disorders.
Cognitive training on an app
This new treatment authorized by the American administration is Rejoyn, a smartphone application created by Otsuka Pharmaceutical and Click Therapeutics. It is intended for patients (from 22 years old) who have been diagnosed with major depressive disorder and are taking antidepressant treatment. For six weeks, the app enables a new approach called cognitive-emotional training and cognitive-behavioral therapy classes.
An application that does not replace medication
Rejoyn is offered in addition to the usual treatments for depression, such as antidepressants, and not as a replacement for them. Among the exercises offered, the app suggests a kind of cognitive and emotional training called the Emotional Faces Memory Task, in which patients are asked to identify and compare the emotions displayed on a series of faces.
“Rejoyn represents a new and exciting adjunctive treatment option to treat symptoms of major depressive disorder that complements the current standard of care” explains Dr. John Kraus, executive vice president and chief medical officer of Otsuka, in a statement. “Although traditional approaches are often effective, many achieve only a partial response to treatment.” he adds.
Authorization based on the results of an inconclusive clinical trial
FDA approval for Rejoyn was granted based on results from a clinical trial involving 386 people ages 22 to 64. All were diagnosed with major depressive disorder unresponsive to antidepressants. They were divided into two groups: one using the Rejoyn app, the other a dummy app that gave memory tasks that did not involve cognitive-emotional training or cognitive-behavioral therapy.
Result: Although participants using the Rejoyn app showed improvement in depressive symptoms compared to baseline, the average change was not significantly different from the change observed with the sham app.
An application that will be available at the end of 2024
Questioned by our colleagues at CNN, Dr. John Tourous, director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston, indicates that “if the benefit is minimal the risks are minimal, perhaps there is no harm in trying it. I hope we see more evidence emerge in the future, because as a clinical psychiatrist, I want to make sure patients are using something that helps them get better.”
Other work shows that these exercises could stimulate the amygdala and the dorsolateral prefrontal cortex, two regions of the brain suspected of being involved in depression – and have antidepressant effects. According to the press release, Rejoyn will require a prescription to download and will be available in late 2024. Otsuka Pharmaceutical said it would work to make the tool “accessible and affordable,” but did not specify its price.
Slide: The main causes of depression