CT-152, a prescription digital therapeutic for Major depressive disorder: a real-world analysis of durability of treatment effect
J. Cochran1, H. Jiang1, H. Saboonchi1, R. Valandas1, Z. Zhang1, A. Vashist1, A. Kulkarni1, S. Bhattacharjee2, V. Nguyen2, T. Carlton1, A. Forbes1, B. Rothman1, M. Slomkowski1, A.J. Rush3
1Otsuka Pharmaceutical Development & Commercialization, Inc., Development & Commercialization, Princeton, United States, 2Employee of Otsuka Pharmaceutical Development & Commercialization, Inc. at the time the study was conducted, Development & Commercialization, Princeton, United States, 3Duke-National University of Singapore Medical School, Behavioral Medicine & Neurosciences Division, Durham, United States
Background: CT-152 is a US Food and Drug Administration cleared 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.
Aims & Objectives: In order to understand the durability of the CT-152 treatment effect, a single-arm observational study was conducted among CT-152 Mirai (NCT04770285) trial responders by linking real-world healthcare claims data via tokenization.
Method: 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 emergency room (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-Åsberg 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.
Discussion & 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.
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