Study of Virtual Reality-based Medical Device for Patients With Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title: Prospective, Multicenter, Assessor-blind, Randomized, Comparative, Pivotal Study to Evaluate the Efficacy and Safety of Wearable Visual Device (HMD)-VR-based Software Medical Device(OMNIFIT DTx-MDD) for Patients With Depressive Disorder

Status Enrolling by invitation

Clinical Trial Summary

This study apply a wearable visual device (HMD)-VR-based software medical device for patients with depressive disorder for 8 weeks.

The investigator would like to confirm evaluate the safety and efficacy of the wearable visual device(HMD)-VR-based software medical device effect of improving depressive disorder in patients.

Clinical Trial Description

Trial subject is a mild and moderate patients diagnosed with depressive disorder The test group is a wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD) and patients who have received standard treatment.

The number of subjects is 162(Two groups, 81 people per group, 15% dropout rate included) Participating institutions are five including Catholic University of Korea Seoul ST.

The clinical trial method is as follows. Subjects who are satisfied with all selection/exclusion criteria and agree to participate in clinical trials are classified into groups that combine test software medical devices and standard treatment based on Visit 2 (Baseline) and groups that perform simple standard treatment. After that, necessary tests are performed at 2, 4, 6, and 8 weeks, and changes in depressive disorder and depressive disorder evaluation scale are confirmed, and safety is evaluated. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Episode
• Major Depressive Disorder

• NCT number: NCT05701345
• Study type: Interventional
• Source: Omni C&S
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 9, 2023
• Completion date: December 15, 2024