Rejoyn is a prescription digital therapeutic (PDT) developed by Otsuka and Click Therapeutics, and commercialized by Otsuka Precision Health, Inc. It is the first and only FDA-cleared PDT for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients (age 22 and older) who are on antidepressant medication.
The program is delivered via a smartphone app and consists of a six-week treatment schedule. It is designed to enhance cognitive control of emotion by leveraging the brain's natural ability to change, known as neuroplasticity.
Key Features and Capabilities:
- Cognitive Emotional Training (CET): The core of the treatment involves clinically-validated brain-training exercises, such as the Emotional Faces Memory Task (EFMT), designed to target neural networks affected by depression.
- Skills-Based Therapy Lessons: The app includes short, animated, skills-based therapy lessons (some CBT-based) to complement the brain exercises.
- Adjunctive Treatment: It is intended to be used alongside existing antidepressant medication and does not replace standard care.
- Digital Delivery: The program is accessed via a mobile app on iOS and Android devices, requiring a prescription and a digital access code.
- Duration: The active treatment program lasts for six weeks, with continued access to completed lessons for an additional four weeks.
Rejoyn is classified as a Class II medical device and was cleared by the FDA in March 2024. Clinical trials showed that adding Rejoyn to antidepressant medication reduced depression symptoms with zero treatment-related adverse events.