2024-04-05 17:15:00
The U.S. Food and Drug Administration (FDA) has cleared the first prescription digital therapeutic treatment authorized for the adjunctive treatment of symptoms of major depressive disorder (MDD).
The approval is for Rejoyn, a six-week treatment program that can improve cognitive control of emotions as an adjunct to physician-managed outpatient care for adult MDD patients (age 22 and older) taking antidepressant medications.
Rejoyn has a neuromodulatory mechanism designed to act as physical therapy for the brain by delivering consistent, personalized brain training exercises designed to help improve connections in brain regions affected by depression. When stronger, more balanced connections are created, the brain regions responsible for processing and regulating emotions can work better together and symptoms of depression can improve.
The approval was based on the 13-week Mirai study, which included 386 participants, ages 22 to 64, diagnosed with MDD and taking antidepressant medication. Among participants who were randomly assigned to receive Rejoyn or a sham control app, individuals treated with Rejoyn showed improvement in the severity of depression symptoms from baseline.
Symptom improvement was consistently detected on patient- and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale, the Patient Health Questionnaire nine-item depression scale, and the Depression Severity Scale. overall clinical impression. Participants in the Rejoyn group showed continued improvement one month after completing the six-week treatment program. No treatment-related adverse events were observed.
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