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.

Stacie Hudgens¹, Intan Purnajo¹, Lysbeth Floden¹, Steve Hwang², Jessica Ash², Brian Rothman², Austin Speier³, Ainslie Forbes²

¹Clinical Outcomes Solutions Ltd., Tucson, AZ, United States.

²Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Drive, Princeton, NJ, 08540, United States, 1 609 524 6788.

³Click Therapeutics, Inc., New York, NY, United States.

PubMed DOI

Abstract

BACKGROUND: Rejoyn (CT-152) is a prescription digital therapeutic (DTx) adjunct to antidepressive medication authorized for patients with major depressive disorder. To better understand the patient benefit of DTx and other treatment modalities, current regulatory standards support the use of modern psychometric methods to interpret the clinical meaningfulness of treatment effects for patients. In…

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