Digital Therapeutic Rejoyn May Aid Anxiety in MDD Patients
The digital therapeutic Rejoyn (CT-152) outperformed a sham smartphone app in reduction of anxiety levels in adult patients with major depressive disorder (MDD). Findings from the post-hoc analysis of the Mirai trial were presented via poster at the 2025 Psych Congress in San Diego, CA.
Rejoyn is a US Food and Drug Administration (FDA)-authorized prescription digital therapeutic adjunct to antidepressant treatment in patients with MDD. In the Mirai trial, Rejoyn showed greater benefit over sham on multiple outcome measures for MDD.
As Rejoyn is “designed to promote emotional regulation and reduce pervasive thinking,” study authors conducted a post-hoc analysis to evaluate the efficacy of Rejoyn versus sham for comorbid baseline anxiety in participants with MDD. The primary outcome was change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale.
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For the Mirai trial, which ran for 6 weeks of intervention plus 4 weeks of extension, adults aged 22 to 64 years old (n=386) who had MDD and reported inadequate response to antidepressant treatment were randomly assigned to Rejoyn plus cognitive-emotional and behavior therapy (n=194) or sham smartphone apps plus a memory-task (n=192). All participants continued their antidepressant medication. Researchers used a mixed-effects model to assess GAD-7 total score and line items to repeatedly measure Rejoyn versus sham groups from baseline to week 6 in those with baseline anxiety (GAD-7³10; n=159).
Overall, Rejoyn showed a numerically greater reduction and nominal significance for GAD-7 total score and 5 of 7 line items compared to sham, (P<0.05). The greatest improvements were seen in line items rated more severe at baseline.
“While not designed for anxiety, these findings support how Rejoyn may target shared symptomology and be effective for those with depression and comorbid anxiety,” the authors concluded.
This study was sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Reference
Stamatis C, et al. Evaluating changes in anxiety symptoms with Rejoyn (CT-152) among participants with major depressive disorder and comorbid anxiety. Poster presented at Psych Congress; September 17-21, 2025; San Diego, California.
