The first prescription ‘digital therapeutic’ authorized for the treatment of major depressive disorder (MDD) symptoms has been approved by the US Food and Drug Administration (FDA). It has been cleared for use as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.
The smartphone app, named Rejoyn, was developed via a partnership of Click Therapeutics, a company that makes software-based medical treatments, and Otsuka Pharmaceuticals.
The FDA cleared the app based on a 13-week study of 386 people ages 22 to 64, in which participants showed improvement in their baseline depression symptoms when using it, compared to a sham app as measured via established clinical scales. The trial also showed continuing improvement a month after treatment, and reported no adverse effects. Rejoyn aims to further reduce MDD symptoms by complementing standard-of-care drug regimens, with a six-week digital treatment schedule that provides cognitive emotional training exercises and therapeutic lessons. The app also offers personalized reminders and messages to encourage adherence to medication.
Unlike therapy apps that are currently available as a “treatment for depression” or “supplemental treatment” and can be downloaded from smartphone App Stores, a prescription from a healthcare provider is needed to access Rejoyn.
The app is not meant to be used as a standalone therapy nor as a substitute for medication.
The website https://www.rejoynhcp.com/ states that the app will be available in Summer 2024.
Otsuka Press Release