Supporting the Primary Outcomes of the Mirai Trial for the Adjunctive Digital Therapeutic Rejoyn (CT-152) in the Treatment of Major Depressive Disorder: Meaningful Change Analysis in the Montgomery-Åsberg Depression Rating Scale.
JMIR Form ResSep 21, 2026 (epub)
Clinical ResearchPsychiatry
Stacie Hudgens, Intan Purnajo, Lysbeth Floden et al.
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In 30 seconds
This randomized controlled trial analyzed the adjunctive digital therapeutic Rejoyn (CT-152) for major depressive disorder, focusing on the Montgomery-Åsberg Depression Rating Scale (MADRS). The study established meaningful within-patient change (MWPC) thresholds of 8 and 10 points, showing that the Rejoyn group had 24%-47% higher odds of meaningful improvement compared to the sham group.
Key findings
- Rejoyn group had 24%-47% higher odds of meaningful improvement on the MADRS compared to the sham group.
- MWPC thresholds of 8 and 10 points were established using CGI-S and PHQ-9 as anchor measures.
- Post hoc analyses favored the Rejoyn group for response rates and changes in PHQ-9 and CGI-S scores.
Why it matters
Understanding the clinical meaningfulness of treatment effects is crucial for clinicians to interpret patient outcomes effectively. This study provides a framework for assessing the impact of digital therapeutics in managing major depressive disorder.