NCT05701345

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Omni C&S · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depressive Disorder
• Major Depressive Disorder
• Depressive Episode

Interventions

Type	Name	Description
DEVICE	OMNIFIT DTx-MDD	This software medical device consists of multifaceted interventions (breathing training, cognitive rehabilitation training, binaural beat training, concentration training) that help improve depressive disorder, and is automatically executed for 35 minutes per session
OTHER	standard treatment	It is based on the Korean Medical Association's clinical treatment guidelines for depression or the Korean Medical Association's Korean Medical Association/Korean Depression Management Association's 2021 guidelines for drug treatment for depression disorders. Standard treatment will be performed according to the judgment of the attending physician reflecting the clinical situation based on these treatment guidelines.

Timeline

• Start date: 2023-03-09
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-01-27
• Last updated: 2024-11-04

Locations

5 sites across 1 country: South Korea