Depression: First digital treatment approved – What is and what Rejoyn app does to mobile phones

The green light received from the American Food and Drug Organization (FDA) the first digital for . This is the “Rejoyn” application that can be installed on our mobile phones. The “Rejoyn” app for smartphone will be the first prescribed digital treatment for depression, namely major depression disorder. It was approved by the American Food and Drug Organization (FDA). This is an application for smart mobile phones intended for use in combination with antidepressants from people aged 22 years or older diagnosed with major depressive disorder. “Rejoyn”, as the app is called, uses a six-week program that combines a new approach to cognitive-emotional education and cognitive behavior therapy courses. Since the Rejoyn application has been classified as a low to medium-risk medical device, it only needed to be shown to be largely equivalent to some other device on the market – meaning it is equally safe and effective – to obtain approval from the FDA. What depression is Depression is one of the most common mental health disorders in the US. About 18% of American adults—more than 1 out of 6 say they are suffering from depression or receiving treatment for depression, according to Gallup report in 2023. According to the same data, up to 30% of people taking antidepressant drugs do not respond fully to treatment, meaning they continue to have symptoms of depression during drug use. The application uses a form of cognitive-emotional education called Emotional Faces Memory Task, in which people are asked to recognize and compare emotions that appear in a range of faces. Preliminary research shows that these exercises may stimulate the amygdala and dorsal prefrontal cortex – areas of the brain believed to be involved in depression – and have antidepressant effects. Rejoyn has a neuromodifying mechanism designed to function as a “natural therapy for the brain” providing personalized, consistent brain training exercises designed to help improve connections in the regions of the brain affected by depression,” said Dr. Brian Iacoviello, a scientific advisor to Click Therapeutics and co-founder of the Emotional Faces Memory Task. The FDA authorisation for Rejoyn was granted based on clinical trial results involving 386 subjects aged 22 to 64 with a diagnosis of major depressive disorder that did not respond to antidepressants. They were assigned to use either the Rejoyn application or a virtual application giving memory tasks that did not include cognitive-emotional education or cognitive behavioral therapy. The study found that while participants using the Rejoyn application showed improvement in symptoms of depression, the mean change was not significantly different from the change observed with placebo. No side effects were reported in the trial. However, as Dr. John Torous, director of the Department of Digital Psychiatry at Beth Israel Deaconess Medical Center, who did not participate in the development of the Rejoyn application, while it is important to note that the test did not prove that Rejoyn has a statistically significant benefit, the application is not designed as an autonomous treatment. “If the benefit is minimal, but the risks are minimal, it may not be bad to try it,” he said. source:

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