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

Primary Purpose

Depressive Disorder, Major Depressive Disorder, Depressive Episode

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OMNIFIT DTx-MDD
standard treatment
Sponsored by
Omni C&S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring mild and moderate depressive disorder

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Inje University Ilsan Palk Hospital
  • Jeju National University Hospital
  • Seoul ST. Mary's Hospital
  • Yeouido ST. Mary's Hospital
  • ST. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

medical device used group

medical device unused group

Arm Description

Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)

Patients receiving only standard treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 12, 2023
Last Updated
March 22, 2023
Sponsor
Omni C&S
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1. Study Identification

Unique Protocol Identification Number
NCT05701345
Brief Title
Study of Virtual Reality-based Medical Device for Patients With Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omni C&S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major Depressive Disorder, Depressive Episode
Keywords
mild and moderate depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multiple-Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
medical device used group
Arm Type
Experimental
Arm Description
Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
Arm Title
medical device unused group
Arm Type
Placebo Comparator
Arm Description
Patients receiving only standard treatment
Intervention Type
Device
Intervention Name(s)
OMNIFIT DTx-MDD
Other Intervention Name(s)
Wearable visual device-based software medical device
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
standard treatment
Other Intervention Name(s)
Antidepressant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of change in Hamilton Depression Rating Scale total score
Description
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
Secondary Outcome Measure Information:
Title
Comparison of response rate and remission rate by Hamilton Depression Rating Scale
Description
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
Title
Comparison of Changes in Patient Health Questionnaire-9 Scores
Description
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
Title
Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression
Description
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
Title
Comparison of side effects
Description
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
Title
Comparison of adverse events
Description
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
Title
Comparison of dropout rates
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngsup Woo
Organizational Affiliation
Yeouido St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Palk Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeouido ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
ST. Vincent's Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

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

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