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

The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder.

The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder. 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. Since Rejoyn is classified as a low- to medium-risk medical device, it needed only to prove that it is “substantially equivalent” to another marketed device – meaning it is just as safe and effective – to gain FDA clearance. “Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said in the release. “While traditional approaches are often effective, many are left with only a partial response to treatment.” Depression is one of the most common mental health disorders in the US. About 18% of American adults – more than 1 in 6 – say they are depressed or receiving treatment for depression, a 2023 Gallup report found. Research has also found that up to 30% of people who take antidepressant medications are partial responders, meaning they continue to have depressive symptoms while using the drugs. Rejoyn is designed to serve as an adjunct to antidepressants for these partial responders, according to the news release. The app uses a form of cognitive-emotional training called Emotional Faces Memory Task, in which people are asked to identify and compare emotions displayed on a series of faces. Preliminary research shows that these exercises may stimulate the amygdala and the dorsolateral prefrontal cortex – regions of the brain that are thought to be involved in depression – and have antidepressant effects.