Rejoyn, developed by Otsuka Precision Health in partnership with Click Therapeutics, is the first-and-only prescription digital therapeutic FDA-cleared for treating major depressive disorder (MDD) symptoms as an adjunct to antidepressant medication in adults 22 and older. Unlike other digital mental health solutions that rely on cognitive behavioral therapy, Rejoyn differentiates itself with a focus on cognitive-emotional training. A team of psychiatrists, psychologists, and neuroscientists at the Icahn School of Medicine at Mount Sinai developed the core treatment component to target the neural network responsible for cognitive control of emotion, which does not function as well in people with depression. The six-week treatment program centers on the emotional faces memory task (EFMT), designed to improve communication between brain regions responsible for processing emotion by tapping into neuroplasticity.
Clinical Trial Results and Safety
Rejoyn was evaluated in the Mirai study, a multicenter, masked, randomized controlled trial with 386 participants ages 22 to 64 already on antidepressant medication. Trial participants reported that Rejoyn reduced their depression severity from moderately severe to mild, and clinicians reported reduction from moderately ill to mildly ill. The clinical trial found no adverse events related to Rejoyn and there are no known contraindications. Based on a meta-analysis of depression treatment publications, the effect size seen with Rejoyn is comparable to standard first-line antidepressants and other augmentation therapies, but without treatment-related adverse events. Rejoyn complements patients’ existing mental health treatment but does not replace it; patients should continue their current treatment as directed and it is not intended to be used as a standalone therapy or a substitute for medication.
Access and Future Direction
The full six-week treatment program costs $200, with discounts available bringing the cost down to $50 for patients without insurance coverage. A limited number of payors such as Highmark currently cover prescription digital therapeutics, and Otsuka Precision Health is actively negotiating agreements with provider and payer groups. All Rejoyn users have the choice to opt into nurse support as part of their treatment. The company does not use AI to deliver treatment but anticipates future use cases for incorporating AI into prescription digital therapeutics, mental health monitoring, and personalized treatment recommendations. Over the next 12 to 24 months, Otsuka aims to raise awareness among patients and healthcare providers with the goal of making Rejoyn part of the standard of care for depression.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.psychiatrist.com/news/inside-rejoyn-a-breakthrough-for-major-depression/