Study of Virtual Reality-based Medical Device for Patients With Depressive Disorder
Depressive Disorder, Major Depressive Disorder, Depressive Episode
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring mild and moderate depressive disorder
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)
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
Experimental
Placebo Comparator
medical device used group
medical device unused group
Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
Patients receiving only standard treatment