Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors


FDA clearance of Rejoyn the first prescription digital therapeutic authorized in the U.S. for the treatment of major depressive disorder – Otsuka

Written by | 10 Apr 2024 | Mental Health

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the FDA has cleared Rejoyn (developed as CT-152), the first prescription digital therapeutic authorized in the U.S. for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older

Rejoyn is a six-week treatment program 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. Unlike wellness apps, the Rejoyn app is a medical device cleared by the FDA for prescribing by a healthcare professional.</p.

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “While traditional approaches are often effective, many are left with only a partial response to treatment. Otsuka has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise. We are deeply grateful to the trial participants, clinicians and everyone at Otsuka and Click Therapeutics, who helped Rejoyn reach this important milestone.”

Rejoyn requires a prescription from a healthcare provider in the U.S. and is expected to be available to patients in the U.S. for download from app stores for iOS and Android operating systems in the latter half of 2024.

The clearance 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, diagnosed with MDD who were on antidepressant medication for the treatment of depression ,

In the trial, patients were randomized to receive either Rejoyn or a sham control app. Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline.

Symptom improvement was consistently observed across multiple patient and clinician-reported scales, including 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). One month after completing the six-week treatment program, participants in the Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during the trial.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.


You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.