FDA clears first prescription digital app named Rejoyn to treat Depression

Food and Drug Administration (FDA) has approved the first-ever “prescription digital therapeutic” smartphone app, Rejoyn, designed to aid in the treatment of major depressive disorder (MDD). Developed by Otsuka America Pharmaceutical, Rejoyn is intended to be used alongside traditional antidepressant medication and talk therapy, serving as an innovative adjunctive treatment for individuals struggling with MDD symptoms.
Dr. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, expressed enthusiasm about this milestone in mental health care. He emphasized that Rejoyn represents a promising additional treatment option that complements the current standard of care for MDD, highlighting its potential impact on managing depressive symptoms.
Major depressive disorder affects approximately 21 million American adults, characterized by persistent feelings of sadness, loss of interest in daily activities, and various cognitive and physical symptoms that can significantly impact one’s quality of life.
Rejoyn operates as a medical device requiring a prescription from a healthcare provider. It consists of a structured six-week program incorporating cognitive behavioral therapy (CBT) lessons and brain-training exercises. The app’s core exercise, the Emotional Faces Memory Task, aims to modify neural connections associated with emotion processing, potentially alleviating depressive symptoms.
The FDA clearance of Rejoyn was based on promising preliminary research demonstrating its ability to stimulate brain areas involved in depression and produce antidepressant effects. Notably, a recent 13-week study revealed that Rejoyn users exhibited a higher response rate compared to individuals using a placebo app (“sham” app), with those adhering to the program showing notable improvement over time.
Mental health experts have cautiously welcomed this new treatment option. Dr. Hillary Ammon, Assistant Professor of Psychiatry at the University of Pennsylvania’s School of Medicine, emphasized the convenience of using Rejoyn alongside traditional care, particularly due to its accessibility and ability to provide daily tasks and reminders. Dr. Thea Gallagher, Clinical Assistant Professor at NYU Langone Health, noted the potential benefits of using Rejoyn between therapy sessions, offering additional support and structure for individuals with MDD.
Despite the app’s efficacy being marginally higher than the placebo, experts underscored the value of exploring alternative treatments, especially for individuals who have not responded well to conventional interventions. Rejoyn is anticipated to become available later this year.

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