NCT05701345Completed
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 · Last updated 4 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 12 Jan 2023
- Start date
- 9 Mar 2023
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Omni C&S
- Diseases
- Depression
- NCT number
- NCT05701345
What you commit to
- Study type: Interventional
- Participants enrolled: 162
- From 9 Mar 2023 to the primary completion date, 1 Nov 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episode
- Current treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodes
Other illness
- 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
- 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)
Other
- if you are pregnant
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 19 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inje University Ilsan Palk Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Unknown status |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Unknown status |
| Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.