Poster
19
(#19) Assessment of efficacy outcomes based on treatment adherence to Rejoyn (CT-152), a digital therapeutic for patients with major depressive disorder, during the Mirai trial
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), the Rejoyn group showed high adherence, with an increased benefit on the Montgomery-Åsberg Depression Rating Scale (MADRS) for participants that completed more sessions. This post hoc analysis assessed the efficacy of Rejoyn versus sham based on participant adherence using the Patient Health Questionnaire 9-Item (PHQ-9), an assessment commonly used in clinical practice.
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) or sham (n=192) smartphone apps. All participants continued their current antidepressant medication. Participants were defined as adherent by completing ≥12/18 sessions. In this analysis, adherence groups were 12/18, ≥12/18, and 18/18 completed sessions. PHQ-9 total score was assessed for each adherence group via mixed-effects model for repeated measures for Rejoyn versus sham groups from baseline to week 6 for all participants. P values were not powered; effect size is reported as Cohen's d.
Results: Rejoyn was favored over sham on the PHQ-9 overall, with nominal significance for those that completed ≥12/18 (protocol-defined adherence; P 0.01, d=0.345) and 18/18 sessions (P 0.05, d=0.422).
Conclusions: Greater improvement in depression symptoms on the PHQ-9 for participants that completed more Rejoyn sessions was consistent with prior analyses on the MADRS. Findings further support the importance of adhering to the Rejoyn treatment regimen for maximizing therapeutic benefit.
Short Description: Rejoyn (CT-152) is the first US FDA-authorized prescription digital therapeutic for treatment of MDD symptoms. Prior analyses suggested that completion of more sessions improved depression symptoms on the MADRS. This post-hoc assessed efficacy of Rejoyn versus sham based on adherence, using the clinically common PHQ-9. Those who completed ≥12/18 and 18/18 sessions showed improved outcomes versus sham, consistent with prior analyses. Findings further support the importance of treatment adherence to Rejoyn for maximizing therapeutic benefit.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc. Click Therapeutics, Inc. was a co-development collaborator.
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) or sham (n=192) smartphone apps. All participants continued their current antidepressant medication. Participants were defined as adherent by completing ≥12/18 sessions. In this analysis, adherence groups were 12/18, ≥12/18, and 18/18 completed sessions. PHQ-9 total score was assessed for each adherence group via mixed-effects model for repeated measures for Rejoyn versus sham groups from baseline to week 6 for all participants. P values were not powered; effect size is reported as Cohen's d.
Results: Rejoyn was favored over sham on the PHQ-9 overall, with nominal significance for those that completed ≥12/18 (protocol-defined adherence; P 0.01, d=0.345) and 18/18 sessions (P 0.05, d=0.422).
Conclusions: Greater improvement in depression symptoms on the PHQ-9 for participants that completed more Rejoyn sessions was consistent with prior analyses on the MADRS. Findings further support the importance of adhering to the Rejoyn treatment regimen for maximizing therapeutic benefit.
Short Description: Rejoyn (CT-152) is the first US FDA-authorized prescription digital therapeutic for treatment of MDD symptoms. Prior analyses suggested that completion of more sessions improved depression symptoms on the MADRS. This post-hoc assessed efficacy of Rejoyn versus sham based on adherence, using the clinically common PHQ-9. Those who completed ≥12/18 and 18/18 sessions showed improved outcomes versus sham, consistent with prior analyses. Findings further support the importance of treatment adherence to Rejoyn for maximizing therapeutic benefit.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc. Click Therapeutics, Inc. was a co-development collaborator.
