An interventional study of OMNIFIT DTx-MDD and standard treatment in Depressive Disorder, Major Depressive Disorder and Depressive Episode, sponsored by Omni C&S. Completed at 5 sites in South Korea. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Omni C&S · Not applicable, Interventional, and Treatment
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.
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.
4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.
This study's enrollment of 162 is above the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →This is the only study on the registry with Omni C&S as lead sponsor.
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Exclusion Criteria:
Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
Device: OMNIFIT DTx-MDD · Other: standard treatment
Patients receiving only standard treatment
Other: standard treatment
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
Also known as: Wearable visual device-based software medical device
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.
Also known as: Antidepressant
Comparison of change in Hamilton Depression Rating Scale total score
The comparison of changes in Hamilton Depression Rating Scale total score between each group is evaluated by Student t-test performing two independent samples. The minimum value is 0 points and the maximum value is 52 points, with higher scores indicating more severe depressive symptoms.
Time frame: 8 weeks
Comparison of response rate and remission rate by Hamilton Depression Rating Scale
chi-squared test or Fisher's exact test is performed to compare response rates (reduction of 50% or more from baseline) and remission rates (Hamilton Depression Rating Scale total score of 6 points or less) by Hamilton Depression Rating Scale between and within groups, and the within-group comparison is based on the frequency of improvement. Evaluate by performing McNemar test for The minimum value is 0 points and the maximum value is 52 points, with higher scores indicating more severe depressive symptoms.
Time frame: 8 weeks
Comparison of Changes in Patient Health Questionnaire-9 Scores
The comparison of changes in the Patient Health Questionnaire-9 score between each group is performed by an independent two-sample student t-test, and the comparison within groups is evaluated by a paired-sample t-test. The Patient Health Questionnaire-9 score has a minimum value of 0 and a maximum value of 27 points, with higher scores indicating more severe depression.
Time frame: 8 weeks
Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression
The comparison of changes in the Clinical Global Impression - Severity \& Clinical Global Impression - Improvement scores between each group is performed by an independent two-sample student t-test, and the comparison within groups is evaluated by a paired-sample t-test. The Clinical Global Impression - Severity \& Clinical Global Impression has a minimum value of 0 and a maximum value of 7 points, with higher scores indicating more severe depression.
Time frame: 8 weeks
Comparison of side effects
Comparison of side effects between each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device.
Time frame: 8 weeks
Comparison of adverse events
Comparison of side adverse events each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device.
Time frame: 8 weeks
Comparison of dropout rates
Comparison of dropout rates events each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device.
Time frame: 8 weeks
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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