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The Food and Drug Administration (FDA) has cleared Rejoyn™ for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD, aged 22 years and older, who are on antidepressant medication. The treatment is intended to reduce MDD symptoms.
Rejoyn is the first prescription smartphone app-based digital therapeutic 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.
The 6-week treatment program consists of 3 parts: cognitive behavioral therapy (CBT)-based lessons, emotional faces memory task exercises, and personalized reminders and messaging. Upon completion of the 6-week program, CBT-based lessons may be revisited for an additional 4 weeks.
The FDA clearance was based on data from the multicenter, remote, double-blinded, randomized, controlled Mirai study (ClinicalTrials.gov Identifier: NCT04770285), which compared Rejoyn to a sham control app in 386 participants aged 22 to 64 years diagnosed with MDD who were on antidepressant medication. The control app included a cognitive training exercise called the shapes memory task. During the treatment period (day 1 [baseline] to week 6), participants had remote telehealth visits.
Findings showed treatment with Rejoyn met the primary endpoint demonstrating a significant mean change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale total score in the intent-to-treat population compared with sham (-8.78 vs -6.66, respectively; treatment difference of -2.12 [95% CI, -3.93, -0.32]; P =.0211). Symptom improvement was also observed using patient-reported (Patient Health Questionnaire-9) and clinician-reported (Clinical Global Impressions-Severity) scales. As for safety, no treatment-related adverse events were reported during the trial.
“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 Brian Iacoviello, PhD, assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, and scientific advisor at Click Therapeutics. “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.”
Rejoyn is expected to be available for download from app stores for iOS® and Android™ in the second half of 2024.
References:
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 (MDD) symptoms. News release. April 1, 2024. https://www.businesswire.com/news/home/20240401758231/en/Otsuka-and-Click-Therapeutics-Announce-the-U.S.-Food-and-Drug-Administration-FDA-Clearance-of-Rejoyn%E2%84%A2-the-First-Prescription-Digital-Therapeutic-Authorized-for-the-Adjunctive-Treatment-of-Major-Depressive-Disorder-MDD-Symptoms.
