Poster
16
(#16) Evaluating changes in anxiety symptoms with Rejoyn (CT-152) among participants with major depressive disorder and comorbid anxiety
Psych Congress 2025
Abstract: Introduction: Rejoyn® (CT-152) is a US Food and Drug Administration-authorized prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD). In the pivotal Mirai trial (NCT04770285), Rejoyn showed benefit over sham on multiple scales for MDD. Rejoyn is designed to promote emotional regulation and reduce perseverative thinking, which may be helpful in MDD and anxiety disorders. This post-hoc analysis assessed the efficacy of Rejoyn versus sham per Generalized Anxiety Disorder 7-Item scale (GAD-7) for participants with comorbid baseline anxiety.
Methods: In Mirai (6-week intervention/4-week extension periods), adults (22-64 years; N=386) with MDD and reported inadequate response to current antidepressant medication were randomly assigned to Rejoyn (n=194; included cognitive-emotional and behavioral therapy) or sham (n=192; included a memory-task) smartphone apps. All participants continued their current antidepressant medication. GAD-7 total score and line items were assessed via mixed-effects model for repeated measures for Rejoyn versus sham groups from baseline to week 6, for those with baseline anxiety (GAD-7≥10; n=159).
Results: Rejoyn was favored over sham with numerically greater reduction and nominal significance for GAD-7 total score and 5 of 7 line items (P 0.05). Line items rated more severe at baseline showed the greatest improvements.
Conclusions: Findings are consistent with prior primary and post-hoc analyses, with Rejoyn favored over sham overall and for multiple GAD-7 line items for those with baseline anxiety. While not designed for anxiety, these findings support how Rejoyn may target shared symptomology and be effective for those with depression and comorbid anxiety.
Short Description: Rejoyn (CT-152) is the first US FDA-authorized prescription digital therapeutic for treatment of MDD symptoms. Primary and post-hoc results support Rejoyn effectiveness for participants with different symptom profiles, including anxiety. This post-hoc assessed efficacy of Rejoyn versus sham for GAD-7 among those with baseline anxiety. Rejoyn was favored overall and for 5 of 7 GAD-7 line items; sham was favored in none. These findings suggest Rejoyn is effective for those with depression and comorbid anxiety.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
Methods: In Mirai (6-week intervention/4-week extension periods), adults (22-64 years; N=386) with MDD and reported inadequate response to current antidepressant medication were randomly assigned to Rejoyn (n=194; included cognitive-emotional and behavioral therapy) or sham (n=192; included a memory-task) smartphone apps. All participants continued their current antidepressant medication. GAD-7 total score and line items were assessed via mixed-effects model for repeated measures for Rejoyn versus sham groups from baseline to week 6, for those with baseline anxiety (GAD-7≥10; n=159).
Results: Rejoyn was favored over sham with numerically greater reduction and nominal significance for GAD-7 total score and 5 of 7 line items (P 0.05). Line items rated more severe at baseline showed the greatest improvements.
Conclusions: Findings are consistent with prior primary and post-hoc analyses, with Rejoyn favored over sham overall and for multiple GAD-7 line items for those with baseline anxiety. While not designed for anxiety, these findings support how Rejoyn may target shared symptomology and be effective for those with depression and comorbid anxiety.
Short Description: Rejoyn (CT-152) is the first US FDA-authorized prescription digital therapeutic for treatment of MDD symptoms. Primary and post-hoc results support Rejoyn effectiveness for participants with different symptom profiles, including anxiety. This post-hoc assessed efficacy of Rejoyn versus sham for GAD-7 among those with baseline anxiety. Rejoyn was favored overall and for 5 of 7 GAD-7 line items; sham was favored in none. These findings suggest Rejoyn is effective for those with depression and comorbid anxiety.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
