Otsuka, Click start fully-remote trial of digital therapeutics to treat depression

Otsuka and Click Therapeutics on Wednesday announced the initiation of a fully-remote clinical trial, dubbed Mirai, to investigate the effectiveness of digital therapeutics as adjunctive therapy in reducing symptoms in adults with major depressive disorder (MDD) who are on antidepressant monotherapy.

Kabir Nath, who heads Otsuka's pharmaceuticals division in North America, said"the COVID-19 pandemic has clearly demonstrated the need for digital treatments and fully remote e-clinical trials," in part to "enhance connectivity between patients and their healthcare team." Meanwhile, Click CEO David Benshoof Klein highlighted "a need for a scalable digital solution that can dramatically expand access to mental health treatment without sacrificing the rigors of clinical validation or a patient-centred focus on engagement and user experience."

Trial to use Verily's Project Baseline

Otsuka and Click will collaborate with Alphabet's Verily subsidiary to execute the fully-remote trial, using Verily's Project Baseline platform. The trial will randomise up to 540 patients to one of two digital therapeutics within the Mirai Study app. As part of the study, subjects will complete a series of brain exercises and check-in with their doctor via video chat, as well as use the Mirai mobile app for six weeks, after which they will complete surveys answering questions about their depression symptoms and health. Efficacy of the Mirai Study app will be evaluated as change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (for further analysis, read Wider View: Going remote doesn’t appear to prolong timeline for Otsuka-Click DTx trial).

In 2019, Otsuka and Click entered a collaboration to develop and commercialise prescription digital therapeutics for patients with MDD (for related analysis, see The Wider View: Click-ing into depression digital therapeutics reinforces Otsuka’s psychiatric drugs stronghold). Under the deal, worth potentially over $302 million, Otsuka agreed to fully fund the development of Click's mobile app for MDD, and to market the app worldwide upon achievement of regulatory approvals. 

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