(#13) CT-152, a Prescription Digital Therapeutic for Major Depressive Disorder: A Real-World Analysis of Durability of Treatment Effect

Abstract: Introduction: CT-152 is a prescription digital therapeutic for treating patients with major depressive disorder (MDD) as an adjunct to antidepressant medication. The durability of CT-152 beyond the clinical trial duration remains unknown. To address this, a single-arm observational study was conducted among CT-152 Mirai (NCT04770285) trial responders by linking real-world healthcare claims data via tokenization. Methods: In Mirai (6-week treatment period/4-week extension), adults with MDD and inadequate response to antidepressant medication were randomly assigned to CT-152 (n=194) or sham (n=192) smartphone app. Participants were offered optional consent for tokenization, a privacy-preserving method for linking participants in clinical trials to their own medical/pharmacy claims. A set of events identifiable via claims indicating loss-of-durability of response to CT-152 were pre-specified: change in antidepressant medication, augmentation, MDD-related hospitalization or ER visit. Proportions of patients with any event were assessed up to 12 months post-trial. Results: Of the 222 participants who consented to tokenization, 64 received CT-152 and achieved at least a partial response (? 30% Montgomery-≈sberg Depression Rating Scale improvement from baseline). Among the 64 tokenized responders, 52 (mean age: 41.3 years; 79% female) were linked to claims data in the post-trial period. Among these participants, 92% did not experience any loss-of-durability events in the 6-month period post-trial, with 90% (45/50) remaining event-free at 9 months and 87% (40/46) at 12 months. Conclusions: The results of this real-world analysis suggest, based on healthcare claims indicating loss-of-durability events, that most CT-152 responders continued to show durability of effect 12 months after the trial.Short Description: CT-152 is a prescription digital therapeutic intended as an adjunct to antidepressant medication in patients with major depressive disorder. In this analysis of the pivotal Mirai trial (NCT04770285), 52 CT-152 responders were linked to real-world healthcare claims data. Among these participants, 92% did not experience any of the pre-specified loss-of-durability events in the 6-month period post-trial, with 90% (45/50) remaining event-free at 9 months, and 87% (40/46) at 12 months.Name of Sponsoring Organization(s): This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc.