Clinical trial · Interventional
Study of Virtual Reality-based Medical Device for Patients with Depressive Disorder
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depressive Disorder | — | UNRESOLVED | — |
| Depressive Episode | — | UNRESOLVED | — |
| Major Depressive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMNIFIT DTx-MDD | Device | — | UNRESOLVED |
| standard treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- medical device used group
- description
- Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
- interventionNames
- Device: OMNIFIT DTx-MDD
- Other: standard treatment
- type
- PLACEBO_COMPARATOR
- label
- medical device unused group
- description
- Patients receiving only standard treatment
- interventionNames
- Other: standard treatment
Primary outcomes (1)
- measure
- Comparison of change in Hamilton Depression Rating Scale total score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available