Trial to Evaluate the Effectiveness of Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder

Summary

Participation Requirements

Description

This is a phase 3, 12-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression. The trial consists of a 2-week screeni...

This is a phase 3, 12-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression. The trial consists of a 2-week screening period, a 6-week treatment period, and a 4-week extension period. All trial visits will be conducted remotely either by video visit or telephone. Eligible subjects will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the subject's personal iPhone or smartphone. The trial population will include male and female subjects between 22 and 64 years of age with a primary diagnosis of major depressive disorder (MDD) who are on an ADT for the treatment of depression. This trial will analyze data gathered from up to 540 subjects in the United States. An interim analysis will be conducted when a targeted sample of the first 180 subjects has completed week 6 or discontinued the trial prior to week 6.

Tracking Information