Otsuka, Click Therapeutics kick off decentralized pivotal trial for depression digital therapeutics

"The randomized controlled trial of the jointly-developed digital therapeutics will be conducted using Verily's Project Baseline and enroll up to 540 patients.
Otsuka Pharmaceutical and Click Therapeutics have announced the launch of a new, fully remote clinical trial being conducted on Verily's Project Baseline platform.

Called the Mirai study, it will be measuring a digital therapeutics intervention's effectiveness in reducing symptoms of depression among adults who have a major depressive disorder (MDD) diagnosis and are on antidepressant monotherapy.
Christoph Koenen, EVP and chief medical officer of Ostuka Pharmaceutical Companies U.S., told MobiHealthNews that the pivotal, randomized, controlled trial will enroll as many as 540 patients across the country over 10 weeks of active participation. The study will be measuring safety and participants' change from baseline on the Montgomery-Åsberg Depression Rating Scale, a standardized measure of depressive symptoms.
Koenen declined to give a hard answer regarding the study's timeline, noting that the size, structure and COVID-19 each introduce uncertainties to that equation. He similarly said that it was too early to share specifics regarding the design of Otsuka and Click's app-based MDD therapy, but noted that it relies on neuroplasticity to drive outcomes...." Lire la suite