NCT04770285

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

A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of a Digital Therapeutic (CT-152) as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 22 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (MDD) who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

Detailed description

This is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression. The trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week extension. Trial visits will be conducted remotely either by video visit or telephone. The screening visit may be performed in person at the discretion of the investigator. Eligible participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iPhone or smartphone. The trial population will include male and female participants 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 approximately 360 participants in the United States. An interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	CT-152 - Digital Therapeutic	CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.
DEVICE	Sham	Sham mobile app was used by the participants as per the schedule specified in the respective arm.

Timeline

• Start date: 2021-02-25
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2021-02-25
• Last updated: 2024-10-16
• Results posted: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study