Study of Virtual Reality-based Medical Device for Patients with Depressive Disorder (NCT05701345) | Clinical Trial Compass
CompletedNot Applicable
Study of Virtual Reality-based Medical Device for Patients with Depressive Disorder
South Korea162 participantsStarted 2023-03-09
Plain-language 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.
Who can participate
Age range19 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Comparison of change in Hamilton Depression Rating Scale total score