FDA Clears First Digital Therapeutic to Treat Major Depressive Disorder


Rejoyn from Otsuka Pharmaceutical and Click Therapeutics is a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises.

The FDA has cleared the first prescription digital therapeutic to treat major depressive disorder (MDD), according to a release.1 CT-152 (Rejoyn) was developed by Otsuka Pharmaceutical and Click Therapeutics, and is authorized to treat MDD symptoms as an adjunct to outpatient care managed by a clinician in adults aged 22 years or older who are taking antidepressant medications.

FDA White Oak Campus headquarters / Tada Images - stock.adobe.com

FDA White Oak Campus headquarters / Tada Images - stock.adobe.com

Rejoyn targets neural networks in the brain that are impacted by depression. According to the release, the digital therapeutic leverages neuroplasticity—or the brain’s innate ability to change and reorganize through experience—to alter connections and reduce symptoms of depression over time. It’s a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises.

About Mirai

Trial Name: Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder (MIRAI)

ClinicalTrials.gov Identifier: NCT04770285

Sponsor: Otsuka Pharmaceutical

Summary: This study compares the effectiveness of 2 digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

“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, scientific advisor at Click Therapeutics, said in a release.1 “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’s approval was based on data from the pivotal phase 3 Mirai (NCT04770285) study, which demonstrated that patients who were treated with the digital therapeutic experienced consistent improvement in depression symptom severity from baseline across several patient and clinician-reported scales.

“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 a release.1 “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.”

READ MORE: Are Psychedelic Therapeutics a New Frontier of Mental Health Treatment?

Mirai was a 13-week, multicenter, remote, double-blinded, randomized, phase 3 controlled trial to compare the effectiveness of Rejoyn or a sham control app. The study cohort included 386 adult patients aged between 22 and 64 years old who were diagnosed with MDD and were taking antidepressant medication. The primary study endpoint was the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to 6 weeks.

The study found that patients treated with Rejoyn experienced an improvement in the severity of their depressive symptoms, which was observed consistently across the MADRS scale, the Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). Additionally, patients treated with Rejoyn continued to show improvement 1 month after completing the initial 6-week program. There were no serious treatment emergent adverse events observed during the study period.

Otsuka Pharmaceutical and Click Therapeutics said that Rejoyn is expected to be available to download from iOS and Android app stores later this year. The digital therapeutic requires a prescription from a health care provider and is not intended to be used as a standalone therapy or as a substitute for medication. There are no contraindications for using Rejoyn.

“Only a third of patients diagnosed with depression and who receive antidepressants as their first-line treatment, are successful,” David Benshoof Klein, co-founder and chief executive officer at Click Therapeutics, said in a release.1 “These patients need new options that capitalize on proven-effective treatment strategies. 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.”

READ MORE: Mental and Behavioral Health Resource Center

1. Otsuka and Click Therapeutics Announce the U.S. 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. Otsuka Pharmaceutical. April 1, 2024. Accessed April 2, 2024. https://otsuka-us.com/news/rejoyn-fda-authorized
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