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Peer-Reviewed Publication
J Affect Disord2025;388119409.November 1, 2025Journal Article

A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study).

Brian Rothman1, Mary Slomkowski2, Austin Speier3, A John Rush4, Madhukar H Trivedi5, Shaheen E Lakhan3, Erica Lawson2, Michael Fahmy2, Daniel Carpenter6, Dalei Chen2, John P Docherty7, Ainslie Forbes2
1Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ 08540, USA. Electronic address: brian.rothman@otsuka-us.com.
2Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ 08540, USA.
3Click Therapeutics, Inc., 80 White St 3rd floor, New York, NY 10013, USA.
4Duke-National University of Singapore Medical School, 8 College Rd, 169857, Singapore.
5Department of Psychiatry, University of Texas Southwestern Medical Center, 1430 Empire Central Dr 1st Floor, Dallas, TX 75247, USA; O'Donnell Brain Institute, University of Texas Southwestern Medical Center, 6124 Harry Hines Blvd. Suite NS03.200, Dallas, TX 75390, USA.
6Otsuka Precision Health, Inc., 508 Carnegie Center Dr, Princeton, NJ 08540, USA.
7Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ 08540, USA; Weill Cornell Medical College, 400 E 67th St, New York, NY 10065, USA.
PubMed DOI

Abstract

OBJECTIVE: Digital therapeutics (DTx) are a new treatment class for major depressive disorder (MDD). This study evaluated the effectiveness and safety of a novel DTx, CT-152 (Rejoyn™), for MDD adjunctive to antidepressant medication monotherapy. METHODS: Adults aged 22-64 years with MDD having an inadequate response to current antidepressant medication monotherapy were enrolled in a phase 3 multi…

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