Background: Rejoyn (CT-152) is a prescription digital therapeutic (DTx) adjunct to antidepressive medication authorized for patients with major depressive disorder. To better understand the patient benefit of DTx and other treatment modalities, current regulatory standards support the use of modern psychometric methods to interpret the clinical meaningfulness of treatment effects for patients. In the primary analysis of Rejoyn from the pivotal phase 3 Mirai trial (NCT04770285), Rejoyn showed a broad risk-to-benefit profile as demonstrated on multiple clinician- and patient-rated scales, including the primary efficacy outcome measure, the Montgomery-Åsberg Depression Rating Scale (MADRS). These findings supported US Food and Drug Administration authorization of Rejoyn as a prescription DTx. However, the clinical relevance of these changes in the MADRS score is not immediately interpretable in clinical practice. Here, we present the results from several post hoc analyses of the Mirai trial data to support the interpretation of clinically meaningful treatment differences on clinician- and patient-reported change in depressive symptoms. Objective: This study had two main objectives: (1) establish threshold parameters that allow for clinically meaningful interpretation of the Mirai results in clinical practice, based on the clinical trial end points of change from baseline in depressive symptoms, and (2) apply this threshold in a responder and sensitivity analysis in the intent-to-treat (ITT) population (which is more frequently reported in pharmacological trials) to further support the interpretation of change in unblinded analysis of the Mirai results. Methods: For the Mirai meaningful within-patient change (MWPC) analysis, anchor-based methods were used to define an MWPC threshold by exploring the associations between the MADRS and the clinician-rated Clinical Global Impression-Severity Scale (CGI-S) and the patient-reported Patient Health Questionnaire 9-Item Scale (PHQ-9). Additional post hoc efficacy analyses (including that of responders) are reported for the ITT population. Results: Using the MWPC thresholds of 8 and 10 points (derived with the CGI-S and PHQ-9 as anchor measures, respectively), the distribution of MADRS responders favored the Rejoyn group over the sham group, and the Rejoyn group had 24%‐47% higher odds of meaningful improvement on the MADRS. Post hoc ITT analyses also favored the Rejoyn group over the sham group for response rates and PHQ-9 and CGI-S score change from baseline. Conclusions: Results are consistent with the primary findings of the Mirai trial, supporting the efficacy of Rejoyn as an adjunctive treatment to antidepressive medication monotherapy for adults with major depressive disorder. The MWPC analyses offered a measure of meaningful change on the MADRS, providing a framework of clinical meaningfulness for the Mirai trial findings.

Rejoyn is now available to the public.

Rejoyn is the first and only prescription app for the treatment of major depressive disorder symptoms.

In April 2024, the United States Food and Drug Administration (FDA) approved the first digital application to treat major depression in adults 22 and older.1 The app—Rejoyn—joins a growing list of art...

In April 2024, the United States Food and Drug Administration approved the first digital application to treat major depression in adults 22 and older.1 The app—Rejoyn—joins a growing list of artificia...

PsychiatryOnline.org is the platform for all American Psychiatric Association Publishing journals, DSM, and bestselling textbooks, as well as APA Practice Guidelines, and continuing medical education.

In April 2024, the United States Food and Drug Administration (FDA) approved the first digital application to treat major depression in adults 22 and older.1 The app—Rejoyn—joins a growing list of art...

Immersive digital therapeutics (DTx) are reshaping the healthcare landscape by enhancing patient outcomes, optimizing clinical operations, and addressing key regulatory challenges. By integrating adva...

In April 2024, the United States Food and Drug Administration approved the first digital application to treat major depression in adults 22 and older.1 The app—Rejoyn—joins a growing list of artificia...

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大塚製薬のニュースリリースをご覧いただけます。

Rejoyn is now available to the public.

The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder.

A new report concludes that mental health apps like Rejoyn and DaylightRx can save money and improve outcomes.

P.Progress in addressing mental health is notoriously slow and often incremental. Breakthrough treatments are often rare and the number of trained professionals is too small to meet the growing demand for services. But as a result of decades of research and post-pandemic attention to mental health issues, 2024 has become a pivotal year. In March, the U.S. Food and Drug Administration (FDA) approved Rejoyn.