Medical Professionals Reference (MPR)FDA Clears Prescription Digital Therapeutic for Major Depressive Disorder

Innovative Digital Therapy for Major Depressive Disorder: A New Horizon in Mental Health Care

The Food and Drug Administration (FDA) has recently cleared Rejoyn™, a novel prescription digital therapeutic, for the adjunct treatment of major depressive disorder (MDD) symptoms in adults. This groundbreaking app combines cognitive emotional training with behavioral therapy, marking a significant advancement in the digital health space and offering a new, evidence-based tool for managing depression alongside traditional pharmacotherapy.

Key Points:

• Rejoyn™ is now FDA-cleared for the treatment of major depressive disorder symptoms in adult patients aged 22 years and older who are currently on antidepressant medication.
• The app is intended to complement clinician-managed outpatient care, providing a multi-faceted approach to depression treatment.
• Rejoyn is the first prescription digital therapeutic that utilizes smartphone technology to deliver a structured treatment program for MDD.
• The therapeutic program includes cognitive behavioral therapy-based lessons, emotional faces memory task exercises, and personalized reminders, extending over a 6-week period with an additional 4-week extension for revisiting CBT lessons.
• Efficacy of Rejoyn was demonstrated in the Mirai study, a multicenter, randomized, controlled trial, where it showed significant improvement in depressive symptoms compared to a control app.
• The primary outcome measured was the change in the Montgomery-Åsberg Depression Rating Scale total score, where Rejoyn users experienced a greater reduction in symptoms.
• Patient-reported and clinician-reported outcomes further validated the symptom improvement observed with Rejoyn.
• No treatment-related adverse events were reported during the trial, highlighting the safety profile of this digital therapeutic.

“When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.”
– Brian Iacoviello, PhD

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