FDA clears prescription digital therapeutic for adults with major depressive disorder

Key takeaways:

• The clearance was based on a study in which adults with MDD used Rejoyn or a sham treatment app for 6 weeks.
• One month after program completion, those treated with Rejoyn showed continued improvement.

The FDA has cleared a first-of-its-kind prescription digital therapeutic to treat major depressive disorder symptoms as an adjunct to clinician-managed outpatient care in adults who have been prescribed antidepressants.

According to a joint release issued by Otsuka Pharmaceutical Co. Ltd. and Click Therapeutics Inc., Rejoyn is a 6-week treatment program that aims to help individuals aged 22 years and older regulate their emotions through a combination of clinically validated cognitive training exercises for the brain and brief therapeutic lessons.

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, said in the release. “While traditional approaches are often effective, many are left with only a partial response to treatment.”

FDA clearance was based on data from the Mirai study, a 13-week, double-blinded, randomized, controlled trial of 386 adults aged 22 to 64 years who were diagnosed with MDD and experiencing what the release termed “inadequate response” to antidepressants. Participants were randomized 1:1 to use either Rejoyn or a sham control app for 6 weeks, with the primary efficacy endpoint the change in Montgomery-Åsberg Depression Rating Scale from baseline to week 6.

Data showed those in the Rejoyn group demonstrated improvement in depression symptom severity from baseline, which was consistently observed across multiple patient and clinician-reported scales including the Patient Health Questionnaire nine-item depression scale and the Clinical Global Impression – Severity scale.

One month after completing the program, per the release, those treated with Rejoyn showed continued improvement.

“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,” Brian Iacoviello, PhD, an assistant professor in the department of psychiatry at Icahn School of Medicine at Mount Sinai and scientific adviser at Click Therapeutics, said in the release.