First Smartphone App to Gain FDA Approval for Depression

Jennifer Middleton, MD, MPH
Posted on April 22, 2024

Last month, the U.S. Food and Drug Administration (FDA) approved a smartphone application (app)—Rejoyn—for the treatment of major depressive disorder as an adjunct to medication treatment. "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.”

The FDA approved Rejoyn on March 20, 2024, after reviewing the results of a randomized controlled trial that enrolled 386 participants 22 to 64 years of age who had major depressive disorder and were also taking medication to treat it. Participants completed either the Rejoyn app’s 6-week course or a sham app course. Researchers compared participants’ Montgomery-Åsberg Depression Rating Scale (MADRS) score before beginning the app course and at the end of the 6 weeks. MADRS scores can range between 0 to 60 points; although the difference in score change between groups was statistically significant, the average between group difference was only 2.12 points. The researchers defined 8 points as a clinically meaningful difference and found that 50.3% of Rejoyn participants met this threshold (compared with 44.9% of the sham group). This data is available on Rejoyn’s website but does not appear to have been published in a peer-reviewed journal yet.

Rejoyn’s 6-week program is a combination of cognitive behavioral therapy–based lessons, emotional faces memory task (EFMT) exercises, and personalized reminders and messaging. EFMT is “designed to enhance cognitive control for emotional information-processing";  participants “identify and compare emotions displayed on a series of faces...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.” (See an example of an EFMT exercise.) The exercises take between 3 to 26 minutes per day and are completed either one at a time 6 days per week or two at a time 3 days a week. The app requires a prescription from a physician, which the patient takes to their pharmacy. The pharmacy then provides a code for the patient to unlock the app, which is compatible with both Apple and Google smartphones. Rejoyn’s cost to patients, and whether it will be covered by insurance, are unknown; it’s due to be released this summer. Hopefully, at some point in the future, we’ll also see data regarding any potential longer-term benefit of its use.

Although Rejoyn is the first (though likely not the last) smartphone app to receive FDA approval for major depressive disorder, other smartphone apps have been studied for this condition. Some of these apps with randomized controlled trial data include SuperBetter, MoodHacker, and SPARX, all of which have modest data suggesting effectiveness in preventing and/or improving major depressive disorder symptoms. Apps are percolating into health care for other conditions (e.g., the iCanQuit app to help with smoking cessation, the AskPCOS app, which provides information about polycystic ovarian syndrome diagnosis and treatment). Multiple apps have FDA approval to guide insulin dosing for persons with diabetes, and patients can also track their blood sugars with apps using Bluetooth-enabled glucose meters. Countless other apps that have been less (or not) robustly studied are also available to consumers. FPM previously reviewed health apps using the SPPACES criteria (Source or developer, Platforms, Pertinence to primary care, Authoritativeness/accuracy/currency of information, Cost, Ease of use, Sponsor[s]). We can and should help guide interested patients toward more reputable apps when possible.

While we wait for more information about Rejoyn, you can read more in the AFP By Topic on Depression and Bipolar Disorders and review FPM’s SPPACES Department Collection.