Psych Congress NetworkFDA Approves First Prescription Digital Therapeutic for Adjunctive Major Depressive Disorder Treatment

FDA Endorses Rejoyn as an Innovative Digital Approach to Supplement Traditional MDD Treatment

The US Food and Drug Administration (FDA) has approved Rejoyn, a pioneering prescription digital therapeutic developed by Otsuka and Click Therapeutics. Designed as an adjunct to existing antidepressant treatments for adults with major depressive disorder, Rejoyn offers a novel, non-invasive option aimed at enhancing cognitive control over emotions through validated brain exercises and therapeutic lessons.

Key Points

• Approval Details: Rejoyn, known during development as CT-152, has received FDA approval for use as a supplementary treatment to clinician-managed care for MDD in adults aged 22 and older who are already receiving antidepressant therapy.
• Prescription Requirement: Unlike general wellness applications, Rejoyn necessitates a prescription, ensuring professional oversight.
• Therapeutic Program: The application features a 6-week program that combines cognitive emotional training exercises with therapeutic lessons aimed at improving brain function related to emotional regulation.
• Development and Efficacy: The included Emotional Faces Memory Task (EFMT) was formulated by experts in psychology, psychiatry, and neuroscience to foster neural connections that influence emotional processing, potentially alleviating symptoms of depression.
• Clinical Trial Results: Based on the Mirai study—a 13-week, double-blinded, randomized controlled trial—participants using Rejoyn showed significant improvements in depression symptoms as measured by several recognized scales.
• Safety Profile: During the trial, no serious adverse effects, treatment discontinuations, or deaths were reported, highlighting the safety of the digital therapeutic.
• Availability: Expected to be accessible through iOS and Android app stores in the latter half of 2024.

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain, helping improve connections in brain regions affected by depression.”
– Brian Iacoviello, PhD, Assistant Professor at the Icahn School of Medicine

More on Device/Drug Approvals