The first digital treatment for depression has received the green light from the US Food and Drug Administration (FDA). It’s regarding the app «Rejoyn» which will be able to be installed on our mobile phones.
The ‘Rejoyn’ app for smartphones will be the first prescription digital therapy for depression and specifically major depressive disorder.
It was approved by the US Food and Drug Administration (FDA).
It is a smart phone application intended for use in conjunction with antidepressant medication by people aged 22 years and older who have been diagnosed with major depressive disorder.
“Rejoyn,” as the app is called, uses a six-week program that combines a new approach of cognitive-emotional training and cognitive behavioral therapy classes.
Since the ‘Rejoyn’ app is classified as a low- to medium-risk medical device, it only needed to be shown to be broadly equivalent to another device on the market – meaning equally safe and effective – to get approval from the FDA.
What is depression
Depression is one of the most common mental health disorders in the US. About 18 percent of American adults—more than 1 in 6—say they suffer from depression or are receiving treatment for depression, according to a Gallup report in 2023. According to the same data, up to 30 percent of people taking antidepressants drugs do not fully respond to treatment, meaning they continue to have symptoms of depression while using the drugs.
The app uses a form of cognitive-emotional training called the Emotional Faces Memory Task, in which people are asked to identify and compare emotions displayed on a series of faces. Preliminary research suggests that these exercises may stimulate the amygdala and dorsal prefrontal cortex – areas of the brain thought to be involved in depression – and have antidepressant effects.
“Rejoyn has a neuromodulating mechanism designed to work like ‘physical therapy for the brain’ by providing personalized, consistent brain training exercises designed to help improve connections in the areas of the brain affected by depression,” said Dr. Brian Iacoviello, scientific advisor to Click Therapeutics and co-inventor of the Emotional Faces Memory Task.
The FDA’s approval of Rejoyn was granted based on the results of a clinical trial involving 386 people aged 22 to 64 with a diagnosis of major depressive disorder unresponsive to antidepressants. They were assigned to use either the Rejoyn app or a virtual app that gave memory tasks that did not involve cognitive-emotional training or cognitive-behavioral therapy.
The study found that while participants using the Rejoyn app experienced an improvement in depression symptoms, the mean change was not significantly different from the change seen with the dummy app.
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 was not involved in the development of the Rejoyn app, points out, while it is important to note that the trial did not prove that Rejoyn has a statistically significant benefit, the application is not designed as a stand-alone treatment.
“If the benefit is minimal but the risks are minimal, it might not hurt to try,” he said.
source: Iatropedia.gr
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