FDA Clears Prescription Digital Therapeutic for Adults with Major Depressive Disorder

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The FDA has recently cleared a groundbreaking prescription digital therapeutic, known as Rejoyn, for the treatment of major depressive disorder (MDD) symptoms in adults. This innovative therapy, developed by Otsuka Pharmaceutical Co. Ltd. in collaboration with Click Therapeutics Inc., aims to provide adjunctive care for individuals who have been prescribed antidepressants as part of clinician-managed outpatient treatment.

Rejoyn is a 6-week treatment program designed to assist individuals aged 22 years and older in regulating their emotions through a combination of clinically validated cognitive training exercises and therapeutic lessons.

The therapy utilizes digital platforms to deliver personalized brain-training exercises, aiming to improve connections in brain regions affected by depression.

Dr. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, expressed enthusiasm about Rejoyn’s potential impact on addressing MDD symptoms. He highlighted the therapy as a novel adjunctive treatment option that complements the existing standard of care. Despite the effectiveness of traditional approaches, many individuals with MDD still experience only partial responses to treatment.

The FDA clearance of Rejoyn was based on data from the Mirai study, a 13-week, double-blinded, randomized, controlled trial involving 386 adults diagnosed with MDD. Participants, aged 22 to 64 years, who exhibited an inadequate response to antidepressants were enrolled in the study.

They were randomized to receive either Rejoyn or a sham control app for 6 weeks, with the primary efficacy endpoint being the change in the Montgomery-Åsberg Depression Rating Scale from baseline to week 6.

Results from the Mirai study demonstrated significant improvements in depression symptom severity among participants in the Rejoyn group compared to the control group. These improvements were consistently observed across various patient and clinician-reported scales, including the Patient Health Questionnaire nine-item depression scale and the Clinical Global Impression – Severity scale.

Furthermore, participants who underwent the Rejoyn treatment continued to experience sustained improvement in depression symptoms even one month after completing the program.

Dr. Brian Iacoviello, an assistant professor at the Icahn School of Medicine at Mount Sinai and scientific adviser at Click Therapeutics, elaborated on Rejoyn’s neuromodulatory mechanism. He likened the therapy to physical therapy for the brain, delivering personalized brain-training exercises to enhance brain connectivity in regions affected by depression.

The FDA clearance of Rejoyn marks a significant milestone in the treatment landscape for MDD, offering a promising adjunctive therapy option for individuals struggling with depression symptoms. With its innovative approach and demonstrated efficacy, Rejoyn has the potential to enhance patient outcomes and expand the range of treatment options available for MDD.


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