After launching a collaboration two years ago, Otsuka and Click Therapeutics are now kicking off a fully remote clinical trial to evaluate digital interventions for adults with major depressive disorder.
The randomized trial will enroll up to 540 participants that are currently taking a single regimen of antidepressants and sign them up online through Verily’s Project Baseline platform.
They will engage with digital cognitive exercises on their own over the course of 10 weeks, and be assessed for any changes on a depression rating scale.
“The COVID-19 pandemic has clearly demonstrated the need for digital treatments and fully remote e-clinical trials that go beyond the pill to empower patients, enhance connectivity between patients and their healthcare team, and ensure more diverse populations can participate in new clinical trials,” said Kabir Nath, president and CEO of Otsuka’s North American pharmaceutical business.
In January 2019, Otsuka inked a deal worth up to $305 million with Click Therapeutics, committing to fully fund the app’s development and lead its worldwide marketing if it’s approved. The app, dubbed CT-152, aims to mimic cognitive therapy principles either alone or in combination with pharmaceutical treatments.
“While awareness of mental illness has grown steadily over the last decade, clinically validated therapeutic options available to patients and providers have remained essentially the same,” said Click CEO David Benshoof Klein. “Now more than ever, there is 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-centered focus on engagement and user experience.”