Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline

altOtsuka launches pivotal trial of digital therapeutics for depression (MedCity News):

Otsuka Pharmaceutical is launching a virtual study to see if digital therapeutics can reduce depression symptoms.

It’s the next step in a partnership between the Tokyo-based drugmaker and Click Therapeutics, a digital health startup that is developing programs for smoking cessation, depression and insomnia.

They plan to enroll up to 540 patients in a randomized, controlled trial that will test the digital therapeutic’s efficacy in patients that are taking antidepressants. The remote trial will be conducted using Verily’s Project Baseline platform…

“Specifically, in mental health, we do think that digital therapeutics will provide additional benefits for patients and that’s the reason why we are not only interested in one intervention but also obviously are committed to broaden this with other approaches that are meant to improve the life of patients,” (Otsuka Chief Medical Officer Christoph) Koenen said. “We do believe that the treatment landscape in mental disease is going to evolve in a way where obviously pharmacotherapy will always play a role, but we do think digital therapeutics can play an additional role, and to some extent, substitute as well as augment pharmacological intervention.”

The Announcement:

Otsuka and Click Therapeutics Initiate First-of-its-Kind Fully Remote Clinical Trial Using Digital Therapeutics as Adjunctive Therapy in Adults With Major Depressive Disorder (press release):

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Click Therapeutics, Inc. announce the initiation of the Mirai study, a landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with major depressive disorder (MDD) who are on antidepressant monotherapy.

Otsuka and Click will collaborate with Verily, a subsidiary of Alphabet, to execute the trial as a fully remote trial. The collaboration with Verily provides tools and technology to engage patients and clinicians, in order to increase the pace of studies and collect higher quality, more comprehensive data in a more naturalistic setting. The collaboration also enables the trial to proceed efficiently and safely in the face of the unique market challenges presented by COVID-19.

News in Context:

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