Clinical trial NCT05701345: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Major Depressive Disorder
Depressive Episode
Keywords: mild and moderate depressive disorder
Lead sponsor: Omni C&S
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 162
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple-Group Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. right-handed men and women
2. If you agree to participate in this clinical trial and voluntarily sign a written consent form
3. If you can understand and cooperate with the contents of this clinical trial
4. If you have a wireless internet(Wifi) environment
5. 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
6. Mild or moderate depressive episodes with a total hdrs score of 7 or more and 24 or less
7. 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:

1. if you are pregnant
2. Schizophrenia, schizoaffective disorder, schizophrenic disorder, or a psychotic disorder not otherwise classified or diagnosed in the past
3. If you have current bipolar disorder or have been diagnosed with bipolar disorder in your past history
4. Accompanied by organic mental disorder, epilepsy/convulsive disorder
5. Current eating disorders, alcohol and other substance-related disorders, and obsessive-compulsive disorder
6. Uncontrolled and unstable clinically significant physical condition
7. In cases where psychiatric evaluation and maintenance of treatment are difficult due to other serious acute physical illnesses
8. If you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episode
9. 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
10. Currently requiring inpatient treatment for a psychiatric disorder other than depressive disorder (ex. alcohol dependence, substance abuse)
11. If the risk of suicide, self-harm, or other harm is judged to be high according to the evaluation of the study director
12. Current depressive episode accompanied by psychotic symptoms
13. Cases in which a therapeutic intervention for a clinical trial cannot be performed due to deterioration of eyesight or hearing
14. Current treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodes
15. Those who are unable to participate in clinical trials due to the judgment of other researchers
16. Those who cannot read the consent form (ex. illiterate, foreigners)

Primary outcomes:
measure: Comparison of change in Hamilton Depression Rating Scale total score
timeFrame: 8 weeks
Secondary outcomes:
measure: Comparison of response rate and remission rate by Hamilton Depression Rating Scale
timeFrame: 8 weeks
measure: Comparison of Changes in Patient Health Questionnaire-9 Scores
timeFrame: 8 weeks
measure: Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression
timeFrame: 8 weeks
measure: Comparison of side effects
timeFrame: 8 weeks
measure: Comparison of adverse events
timeFrame: 8 weeks
measure: Comparison of dropout rates
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Palk Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido ST. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: ST. Vincent's Hospital
Study officials:
affiliation: Yeouido St. Mary's Hospital
name: Youngsup Woo
role: PRINCIPAL_INVESTIGATOR
References: