The U.S. Food and Drug Administration (FDA) has cleared Rejoyn (CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.
Rejoyn is a prescription app-based digital therapeutic that provides 6 weeks of treatment composed of three parts, including Cognitive Behavioral Therapy (CBT)-based lessons, Emotional Faces Memory Task (EFMT) exercises, and personalized reminders and messaging. The mechanism of action of Rejoyn is hypothesized to be mediated through the complementary combination of CBT-based lessons and EFMT exercises. It is theorized to target the neural networks affected by depression and potentially use the brain’s inherent neuroplasticity to alter emotional connections, thus leading to a reduction in symptoms over time.
This clearance is based on data from a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants aged 22 to 64 who were diagnosed with MDD and on antidepressants. Participants were randomized to receive either Rejoyn or a sham control app. Those treated with Rejoyn showed an improvement in depression symptom severity from baseline and symptom improvement was consistently observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire 9-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). Participants in the Rejoyn arm showed continued improvement 1 month after completing the 6-week treatment program. No adverse effects from Rejoyn were observed during the trial.
Rejoyn is anticipated to be available for download from app stores for iOS and Android operating systems later in 2024.