FDA Approves First Prescription Digital Therapeutic for Adjunctive Major Depressive Disorder Treatment

The US Food and Drug Administration (FDA) approved Rejoyn, the first prescription digital therapeutic for the treatment of major depressive disorder (MDD) symptoms. Otsuka and Click Therapeutic's Rejoyn (developed as CT-152) is now authorized as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.

Rejoyn requires a prescription from a health care professional, unlike other wellness apps. The app’s 6-week treatment program "is designed to help enhance cognitive control of emotion through a combination of clinically validated cognitive emotional training exercises for the brain and brief therapeutic lessons," developers said in the news release. The included Emotional Faces Memory Task (EFMT) brain exercises were developed by psychologists, psychiatrists, and neuroscientists to modify neural connections that process emotions, with the aim of reducing depression symptoms.

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” said Click Therapeutics Scientific Advisor and co-inventor of the EFMT brain exercises, Brian Iacoviello, PhD, assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, in a press release. “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.”

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The approval of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants aged 22 to 64 with a current primary diagnosis of MDD who were on antidepressant medication. Patients were randomized to receive either Rejoyn (n = 194) or a sham control app (n = 192) on their personal smartphones. Participants treated with Rejoyn showed an improvement in depression symptom severity from baseline, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). No serious adverse effects, discontinuations, or deaths occurred during the trial.

“The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder. It provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand,” said David Benshoof Klein, co-founder and chief executive officer at Click Therapeutics, in the news release.

The app is expected to be available for download from app stores for iOS and Android operating systems in the latter half of 2024.

Reference

Otsuka and Click Therapeutics announce the US Food and Drug Administration (FDA) clearance of Rejoyn, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder symptoms. News Release. Business Wire. April 1, 2024. Accessed April 30, 2024.