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

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.

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)