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Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study

Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study

The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect (Figure 1). Given the COVID-19 pandemic and the advantages of remote trials, especially for a DTx, MIRAI was run as a remote study. Except the screening visit, all visits took place remotely; the screening visit had an in-person or remote option per investigator and patient preference.

Brian Rothman, Mary Slomkowski, Austin Speier, A John Rush, Madhukar H Trivedi, Erica Lawson, Michael Fahmy, Daniel Carpenter, Dalei Chen, Ainslie Forbes

JMIR Res Protoc 2024;13:e56960

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