FDA Approves Rejoyn: First Prescription App for Major Depressive Disorder

The FDA has approved Rejoyn, the first prescription app for major depressive disorder (MDD). Targeted at adults aged 22 and older who are already on antidepressant medications, Rejoyn provides a 6-week treatment program featuring cognitive-behavioral therapy–based lessons, emotional faces memory task exercises, and personalized reminders and messaging. The app will be available by prescription later in 2024. The pivotal study, the 13-week Mirai trial with 386 participants, showed some improvement in depression symptoms among users, though the results were not statistically significant compared to a sham app.

Despite mixed initial results, experts like Dr. John Torous from Harvard Medical School see potential in Rejoyn as an adjunctive treatment with minimal risk. The app’s approval marks a significant shift in digital mental health treatment, offering new options accessible via smartphones. However, the effectiveness and widespread adoption of Rejoyn will depend on user engagement and adherence. With numerous mental health apps already available, many free or low-cost, clinicians and patients will need guidance on evaluating and choosing the most suitable digital tools for managing depression.

Reference: Ault A. FDA Approves First Prescription App for Depression. Medscape. Published April 05, 2024. Accessed July 15, 2024. https://www.medscape.com/viewarticle/fda-approves-first-prescription-app-depression-2024a10006k9