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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depressive Disorder, Major Depressive Disorder, Depressive Episode

Intervention / Treatment
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* Device: OMNIFIT DTx-MDD
* Other: standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: right-handed men and women If you agree to participate in this clinical trial and voluntarily sign a written consent form If you can understand and cooperate with the contents of this clinical trial If you have a wireless internet(Wifi) environment Diagnosed by a psychiatrist as major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorder 5th edition(DSM-5) or other specified depressive disorder Mild or moderate depressive episodes with a total hdrs score of 7 or more and 24 or less If there was no change in the type and dose of antidepressants and antipsychotics taken within 4 weeks prior to participation in this clinical trial Exclusion Criteria: if you are pregnant Schizophrenia, schizoaffective disorder, schizophrenic disorder, or a psychotic disorder not otherwise classified or diagnosed in the past If you have current bipolar disorder or have been diagnosed with bipolar disorder in your past history Accompanied by organic mental disorder, epilepsy/convulsive disorder Current eating disorders, alcohol and other substance-related disorders, and obsessive-compulsive disorder Uncontrolled and unstable clinically significant physical condition In cases where psychiatric evaluation and maintenance of treatment are difficult due to other serious acute physical illnesses If you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episode Treatment-resistant depressive disorder for which there was no effect even after using two or more antidepressants in sufficient doses and for a sufficient period of time (6 weeks) for the current depressive episode Currently requiring inpatient treatment for a psychiatric disorder other than depressive disorder (ex. alcohol dependence, substance abuse) If the risk of suicide, self-harm, or other harm is judged to be high according to the evaluation of the study director Current depressive episode accompanied by psychotic symptoms Cases in which a therapeutic intervention for a clinical trial cannot be performed due to deterioration of eyesight or hearing Current treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodes Those who are unable to participate in clinical trials due to the judgment of other researchers Those who cannot read the consent form (ex. illiterate, foreigners)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multiple-Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical device used group<br>Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD) | Device: OMNIFIT DTx-MDD<br>* 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<br>* Other names: Wearable visual device-based software medical device;Other: standard treatment<br>* 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.<br>* Other names: Antidepressant;|
| Placebo Comparator: medical device unused group<br>Patients receiving only standard treatment | Other: standard treatment<br>* 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.<br>* Other names: Antidepressant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild and moderate depressive disorder